4385 First Aid Kit

4385 First Aid

Honeywell Safety Products Usa, Inc.
Human Otc Drug
NDC 0498-4385

4385 First Aid Kit also known as 4385 First Aid is a human otc drug labeled by 'Honeywell Safety Products Usa, Inc.'. National Drug Code (NDC) number for 4385 First Aid Kit is 0498-4385. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4385 First Aid Kit drug includes . The currest status of 4385 First Aid Kit drug is Active.

Drug Information:

Drug NDC:	0498-4385
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	4385 First Aid Kit
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	4385 First Aid
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Honeywell Safety Products Usa, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Kit
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	13 Sep, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	11 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Honeywell Safety Products USA, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	486515 797544 1053173
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0302642201105 0669635150759 0364809450337
UPC stands for Universal Product Code.
UNII:
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0498-4385-01	1 KIT in 1 KIT (0498-4385-01) * 118 mL in 1 BOTTLE (0498-0100-02) * .4 mL in 1 POUCH (0498-0143-04) * 500 mL in 1 CONTAINER * .3 mL in 1 POUCH (0498-0121-00) * .0019 L in 1 PACKET	13 Sep, 2018	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

4385 First Aid Kit

4385 First Aid

Kit
Honeywell Safety Products USA, Inc.
NDC: 0498-4385

Purpose:

Eyewassh purpose eyewash

Alcohol wipe purpose first aid antiseptic

Pvp wipes purpose first aid antiseptic

Paws purpose antiseptic

Product Elements:

4385 first aid kit 4385 first aid paws ethyl alcohol aloe vera leaf trolamine water alcohol alcohol pvp iodine wipe povidone-iodine 10% nonoxynol-9 water povidone-iodine iodine eyesaline emergency eyewash purified water sodium phosphate, dibasic sodium phosphate, monobasic, monohydrate sodium chloride water water alcohol wipe isopropyl alcohol water isopropyl alcohol isopropyl alcohol sodium chloride sodium chloride water hydrochloric acid sodium chloride sodium cation chloride ion

Drug Interactions:

Drug interactions some additives may be incompatible. consult with pharmacist.when introducing additives, use aseptic technique.mix thoroughly. do not store.

Indications and Usage:

Eyewash uses for flushing the eye to remove loose foreign material, air pollutants or chlorinated water

Indication and usage nacl irrigant 0.9% sodium chloride irrigation usp is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

Alcohol wipe uses first aid to help prevent infection in minor cuts, scrapes, and burns

Pvp wipes uses first aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Paws uses for handwashing to decrease bacteria on skin whenever soap and water is not readily available

Warnings:

Eyewash warnings for external use only obtain immediate medical treatment for all open wounds in or near eyes. to avoid contamination, do not touch tip of container to any surface. do not reuse. once opened, discard. do not use if solution changes color or becomes cloudy if you have open wounds in or near the eyes, get medical help right away. stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye condition worsens or persists keep out of reach of children if swallowed, get medical help or contact a poison control center right away.

Warnings nacl irrigant for irrigation only. not for injection. irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. absorption of large amounts can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. the risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. do not warm above 150Â°f (66Â°c). after opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. discard unused portion of irrigating solution since it contains no preservatives.

Alcohol wipe warnings for external use only flammable, keep away from fire and flame do not use in or near eyes over large areas of the body ask a doctor before use if you have deep or puncture wounds animal bites serious burns when using this product do not use longer than 1 week unless directed by a doctor stop use and consult a doctor if condition persists or gets worse keep out of the reach of children if swallowed, get medical help or contact a poison control center right away

Pvp wipes warnings for external use only. ask a doctor before use if you have deep or puncture wounds animal bites serious burns stop use and ask a doctor if condition worsens or persists for more than 72 hours irritation and redness develops keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Paws warnings for external use only flammable: keep away from fire or flame do not use in the eyes. if this happens, rinse thoroughly with water. stop use and ask a doctor if irritation or redness develop and persists for more than 72 hours keep out of reach of children if swallowed, get medical help or contact a poison control center right away

Do Not Use:

When Using:

When using this product do not use longer than 1 week unless directed by a doctor

Dosage and Administration:

Eyeash directions remove contacts before using twist top to remove flush the affected area as needed control rate of flow by pressure on the bottle if necessary, continue flushing with emergency eyewash or shower

Dosage and administration as required for irrigation. when used as a diluent, or vehicle for other drugs, the drug manufacturer's recommendations should be followed. some additives may be incompatible. consult with pharmacist. when introducing additives, use aseptic techniques. mix thoroughly. do not store. solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

Alcohol wipe directions clean the affected area may be covered with a sterile bandage apply wipe to affeted are 1 to 3 times daily discard wipe after single use

Pvp wipes directions clean the affected area apply1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first discard wipe after single use

Paws directions wet hands and wrists thoroughly for 15 seconds and allow to air dry always reseal after use children under 6 years of age should be supervised when using this product

Stop Use:

Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye condition worsens or persists

Stop use and consult a doctor if condition persists or gets worse

Stop use and ask a doctor if condition worsens or persists for more than 72 hours irritation and redness develops

Stop use and ask a doctor if irritation or redness develop and persists for more than 72 hours

Contraindications:

Contraindications nacl irrigant 0.9% sodium chloride irrigation usp is not for injection by usual parenteral routes. an electrolyte solution should not be used for irrigation during electrosurgical procedures.

Adverse Reactions:

Adverse reactions possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. accidental contamination from careless technique may transmit infection. if an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Drug Interactions:

Drug interactions some additives may be incompatible. consult with pharmacist.when introducing additives, use aseptic technique.mix thoroughly. do not store.

Use in Pregnancy:

Pregnancy teratogenic effects animal reproduction studies have not been conducted with 0.9% sodium chloride irrigation usp. it is also not known whether 0.9% sodium chloride irrigation usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% sodium chloride irrigation usp should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Pediatric use the safety and effectiveness of 0.9% sodium chloride irrigation usp in pediatric patients have not been established. its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

Geriatric Use:

Geriatric use clinical studies of 0.9% sodium chloride irrigation usp did not include a sufficient number of patients age 65 years and over to determine whether they respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.frequent laboratory determinations and clinical evaluations are recommended to monitor changes in blood glucose, electrolyte concentrations, and renal function.

Overdosage:

Overdosage in the event of overhydration or solute overload, reevaluate the patient's condition, and institute appropriate corrective treatment. intravasular volume overload may respond to hemodialysis. see warnings, precautions, and adverse reactions.

Description:

Description nacl irrigation each 100 ml contains: sodium chloride usp 0.9 g; water for injection usp qs ph adjusted with hydrochloric acid nf ph: 5.0 (4.5â7.0) calculated osmolarity: 310 mosmol/liter concentration of electrolytes (meq/liter): sodium 154; chloride 154 0.9% sodium chloride irrigation usp is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. the formula of the active ingredient is: ingredient molecular formula molecular weight sodium chloride usp nacl 58.44 the plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. the copolymer contains no plasticizers and exhibits virtually no leachability. the plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. the safety of the plastic container has been confirmed by biological evaluation procedures. the material passes class vl testing as specified in the u.s. pharmacopeia for biological tests â plastic containers. these tests have shown that the container is nontoxic and biologically inert. the picâ¢ container is pvc-free and dehp-free. ingredient molecular formula molecular weight sodium chloride usp nacl 58.44 the plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. the copolymer contains no plasticizers and exhibits virtually no leachability. the plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. the safety of the plastic container has been confirmed by biological evaluation procedures. the material passes class vl testing as specified in the u.s. pharmacopeia for biological tests â plastic containers. these tests have shown that the container is nontoxic and biologically inert. the picâ¢ container is pvc-free and dehp-free.

Clinical Pharmacology:

Clinical pharmacology nacl irrigant 0.9% sodium chloride irrigation usp is utilized for a variety of clinical indications such as sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters, surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. it also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations. 0.9% sodium chloride irrigation usp provides an isotonic saline irrigation identical in composition with 0.9% sodium chloride injection usp (normal saline). physiological irrigation solutions are considered generally compatible with living tissues and organs. sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. chloride, the ma Read more...

jor extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility studies with 0.9% sodium chloride irrigation usp have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

How Supplied:

How supplied 0.9% sodium chloride irrigation usp is supplied sterile and nonpyrogenic in picâ¢ (plastic irrigation container). the 1000 ml and 500 ml containers are packaged 16 per case, the 2000 ml containers are packaged 8 per case, and the 4000 ml containers are packaged 4 per case. 0.9% sodium chloride irrigation usp ndc cat. no. ref size 0264-2201-00 r5200-01 1000 ml 0264-2201-10 r5201-01 500 ml 0264-2201-50 r5205-01 2000 ml 0264-2201-70 r5207 ,,,,4000 ml exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. protect from freezing. it is recommended that the product be stored at room temperature (25Â°c); however, brief exposure up to 40Â°c does not adversely affect the product. do not warm above 150Â°f (66Â°c).

Package Label Principal Display Panel:

Eyewash principal display panel eyesaline

Principal display panel 500 ml container nacl irrigation usp

Alcohol wipe principal display panel alcohol preps

Pvp wipes principal display panel pvp wipe

Paws principal display panel paws

4385 kit label 346100 4385 label

Further Questions:

Eyeash questions call 1-800-430-5490 honeywell safety products usa, inc. smithfield, ri 02917

Alcohol wipe questions 1-800-430-5490

Pvp wipes questions 1-800-430-5490

Paws questions 1-800-430-5490

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.