Large Ansi First Aid Kit
Water, Benzalkonium Chloride, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride
Gfa Production (xiamen) Co., Ltd.
Human Otc Drug
NDC 50814-021Large Ansi First Aid Kit also known as Water, Benzalkonium Chloride, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride is a human otc drug labeled by 'Gfa Production (xiamen) Co., Ltd.'. National Drug Code (NDC) number for Large Ansi First Aid Kit is 50814-021. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Large Ansi First Aid Kit drug includes . The currest status of Large Ansi First Aid Kit drug is Active.
Drug Information:
| Drug NDC: | 50814-021 |
| 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: | Large Ansi 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: | Water, Benzalkonium Chloride, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Gfa Production (xiamen) Co., Ltd. |
| 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: | OTC MONOGRAPH FINAL |
| 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: | 09 Aug, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 May, 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. |
| Application Number: | part333B |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2024 |
| 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: | GFA Production (Xiamen) Co., Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 204602
581660
797544
1012100
1038558
1053429
|
| 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. |
| 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 |
|---|
| 50814-021-01 | 1 KIT in 1 KIT (50814-021-01) * 1 BOX in 1 BOX (50814-012-01) / 20 PATCH in 1 BOX / .9 g in 1 PATCH * 1 BOX in 1 BOX (50814-014-01) / 10 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 1 BOX in 1 BOX (50814-013-01) / 10 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 1 BOX in 1 BOX (50814-015-01) / 6 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 2 BOX in 1 BOX (50814-011-01) / 10 PATCH in 1 BOX / .9 g in 1 PATCH * 1 TUBE in 1 BOX (50814-010-01) / 30 mL in 1 TUBE | 09 Aug, 2016 | 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. |
Purpose:
Purpose eyewash
Purpose: first aid antiseptic
Purpose: antiseptic
Purpose first aid antibiotic
Purpose first aid antiseptic pain relieving cream
Purpose antiseptic
Product Elements:
Large ansi first aid kit water, benzalkonium chloride, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine hydrochloride eye wash water benzalkonium chloride sodium chloride water water antiseptic towelettes benzalkonium chloride water benzalkonium chloride benzalkonium alcohol cleansing isopropyl alcohol water isopropyl alcohol isopropyl alcohol antibiotic application bacitracin zinc, neomycin sulfate, polymyxin b sulfate mineral oil petrolatum water bacitracin zinc bacitracin neomycin sulfate neomycin polymyxin b sulfate polymyxin b burn treatment benzalkonium chloride, lidocaine hydrochloride glycerin water benzalkonium chloride benzalkonium lidocaine hydrochloride lidocaine lidocaine hydrochloride hand sanitizer alcohol carboxypolymethylene propylene glycol water titanium dioxide alcohol alcohol
Indications and Usage:
Use for cleansing the eye to help relieve irritation or burning by removing loose foreign material
Use: for professional and hospital use. helps prevent infection. antiseptic cleansing of face, hands and body without soap and water.
Use: for preparation of the skin before injection.
Use first aid to help prevent infection in minor cuts, scrapes, and burns.
Uses first aid to help prevent infection in minor cuts, scrapes, and burns. for the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes
Uses for handwashing to decrease bacteria on the skin recommended for repeated use.
Warnings:
Warnings for external use only. do not use if solution changes color or becomes cloudy when using this product ⢠to avoid contamination, do not touch tip of container to any surface ⢠do not reuse ⢠once opened, discard ⢠obtain immediate medical treatment for all open wounds in or near the eyes stop use and ask a doctor if ⢠you experience: ⢠eye pain ⢠changes in vision ⢠continued redness ⢠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: for external use only. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. if unusual redness, swelling or other symptoms occur, consult a physician immediately. do not use: in the eyes, or over large areas of the body.
Warnings: for external use only. flammable - keep away from fire or flame. do not use: with electrocautery, in the eyes stop use if irritation and redness develop. if condition persists for more than 72 hours, consult your doctor. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings for external use only. do not use ⢠in the eyes ⢠over large areas of the body ⢠if you are allergic to any of the ingredient ⢠longer than 1 week unless directed by a doctor. ask a doctor before use if you have stop use and ask a doctor if ⢠the condition persists or gets worse ⢠a rash or other allergic reaction develops. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings for external use only. do not use ⢠in the eyes ⢠over large areas of the body ⢠in large quantities ⢠over raw surfaces or blistered areas ⢠longer than 1 week unless directed by a doctor ask a doctor before use if you have ⢠deep or puncture wounds ⢠animal bites ⢠serious burns. stop use and ask a doctor if ⢠the condition persists or gets worse ⢠symptoms persist for more than 7 days or clear up and occur again within a few days keep out of reah of children. if swallowed, get medical help or contact a poison control center right away.
Warnings flammable, keep away from fire or flame for external use only. do not use in the eyes. stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours keep out of reach children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for external use only. do not use if solution changes color or becomes cloudy when using this product ⢠to avoid contamination, do not touch tip of container to any surface ⢠do not reuse ⢠once opened, discard ⢠obtain immediate medical treatment for all open wounds in or near the eyes stop use and ask a doctor if ⢠you experience: ⢠eye pain ⢠changes in vision ⢠continued redness ⢠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: for external use only. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. if unusual redness, swelling or other symptoms occur, consult a physician immediately. do not use: in the eyes, or over large areas of the body.
Warnings: for external use only. flammable - keep away from fire or flame. do not use: with electrocautery, in the eyes stop use if irritation and redness develop. if condition persists for more than 72 hours, consult your doctor. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings for external use only. do not use ⢠in the eyes ⢠over large areas of the body ⢠if you are allergic to any of the ingredient ⢠longer than 1 week unless directed by a doctor. ask a doctor before use if you have stop use and ask a doctor if ⢠the condition persists or gets worse ⢠a rash or other allergic reaction develops. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings for external use only. do not use ⢠in the eyes ⢠over large areas of the body ⢠in large quantities ⢠over raw surfaces or blistered areas ⢠longer than 1 week unless directed by a doctor ask a doctor before use if you have ⢠deep or puncture wounds ⢠animal bites ⢠serious burns. stop use and ask a doctor if ⢠the condition persists or gets worse ⢠symptoms persist for more than 7 days or clear up and occur again within a few days keep out of reah of children. if swallowed, get medical help or contact a poison control center right away.
Warnings flammable, keep away from fire or flame for external use only. do not use in the eyes. stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours keep out of reach children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product ⢠to avoid contamination, do not touch tip of container to any surface ⢠do not reuse ⢠once opened, discard ⢠obtain immediate medical treatment for all open wounds in or near the eyes
Dosage and Administration:
Directions ⢠flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle
Directions: tear open packet, unfold towelette and use to cleanse desired skin area. discard towelette appropriately after single use.
Directions: wipe injection site vigorously and discard.
Directions ⢠clean the affected area. ⢠apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. ⢠may be covered with a sterile bandage.
Directions clean the affected area adults and children 2 years of age and older: apply a small amount of this product to affected area not more than 3 times daily children under 2 years of age: consult a doctor may be covered with a sterile bandage
Directions wet hands thoroughly with product and allow to dry without wi
Stop Use:
Stop use and ask a doctor if ⢠you experience: ⢠eye pain ⢠changes in vision ⢠continued redness ⢠irritation of the eye ⢠condition worsens or persists
Stop use if irritation and redness develop. if condition persists for more than 72 hours, consult your doctor.
Stop use and ask a doctor if ⢠the condition persists or gets worse ⢠a rash or other allergic reaction develops.
Stop use and ask a doctor if ⢠the condition persists or gets worse ⢠symptoms persist for more than 7 days or clear up and occur again within a few days
Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours
Package Label Principal Display Panel:
Eye wash (50814-010-01) labeling: eye wash
Antiseptic towelettes 50814-011-01 50814-011-01
Alcohol cleansing 50814-012-01 50814-012-01
Antibiotic application 50814-013-01 50814-013-01
Burn treatment 50814-014-01 50814-014-01
Hand sanitizer 50814-015-01 50814-015-01
Large ansi first aid kit (50814-021-01) labeling: first aid