Johnson And Johnson All Purpose First Aid Kit
Acetaminophen, Diphenhydramine Hydrochloride, Zinc Acetate, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride
Johnson & Johnson Consumer Inc.
Human Otc Drug
NDC 69968-0711Johnson And Johnson All Purpose First Aid Kit also known as Acetaminophen, Diphenhydramine Hydrochloride, Zinc Acetate, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride is a human otc drug labeled by 'Johnson & Johnson Consumer Inc.'. National Drug Code (NDC) number for Johnson And Johnson All Purpose First Aid Kit is 69968-0711. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Johnson And Johnson All Purpose First Aid Kit drug includes . The currest status of Johnson And Johnson All Purpose First Aid Kit drug is Active.
Drug Information:
| Drug NDC: | 69968-0711 |
| 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: | Johnson And Johnson All Purpose 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: | Acetaminophen, Diphenhydramine Hydrochloride, Zinc Acetate, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Johnson & Johnson Consumer 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: | 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: | 16 Aug, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | part348 |
| 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: | Johnson & Johnson Consumer Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198440
209459
1087026
1111764
1359360
|
| 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 |
|---|
| 69968-0711-9 | 1 KIT in 1 PACKAGE (69968-0711-9) * 1 TUBE in 1 CARTON (69968-0223-1) / 28.3 g in 1 TUBE * 1 TUBE in 1 CARTON (69968-0055-2) / 14.2 g in 1 TUBE * 1 CLOTH in 1 PACKET * 2 TABLET, FILM COATED in 1 POUCH (50580-449-08) | 16 Aug, 2021 | 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 pain reliever/fever reducer
Active ingredients purpose diphenhydramine hydrochloride 2% topical analgesic zinc acetate 0.1% skin protectant
Active ingredients (in each gram) purpose neomycin sulfate (3.5 mg) first aid antibiotic polymyxin b sulfate (10,000 units) first aid antibiotic pramoxine hcl (10 mg) external analgesic
Product Elements:
Johnson and johnson all purpose first aid kit acetaminophen, diphenhydramine hydrochloride, zinc acetate, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride tylenol extra strength acetaminophen carnauba wax starch, corn fd&c red no. 40 aluminum oxide hypromellose, unspecified magnesium stearate polyethylene glycol, unspecified powdered cellulose propylene glycol shellac sodium starch glycolate type a potato titanium dioxide acetaminophen acetaminophen tylenol;500 benadryl extra strength itch stopping diphenhydramine hydrochloride and zinc acetate cetyl alcohol diazolidinyl urea methylparaben propylene glycol propylparaben water diphenhydramine hydrochloride diphenhydramine zinc acetate zinc cation neosporin plus pain relief first aid antibiotic/pain relieving neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride water mineral oil petrolatum propylene glycol methylparaben sulfuric acid sodium hydroxide neomycin sulfate neomycin polymyxin b sulfate polymyxin b pramoxine hydrochloride pramoxine johnson and johnson hand cleansing wipes water isopropyl alcohol benzalkonium chloride sodium bicarbonate
Indications and Usage:
Uses temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Uses temporarily relieves pain and itching associated with: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac dries the oozing and weeping of poison ivy, poison oak, and poison sumac
Uses first aid to help prevent infection and for the temporary relief of pain in minor: cuts scrapes burns
Warnings:
Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product ask a doctor before use if you have liver disease ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is p
Read more...resent these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning in case of overdose, get medical help or contact a poison control center right away. (1-800-222-1222) quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Warnings for external use only do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth ask a doctor before use on chicken pox on measles when using this product avoid contact with eyes stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur again within a few days 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 if you are allergic to any of the ingredients in the eyes over large areas of the body ask a doctor before use if you have deep or puncture wounds animal bites serious burns stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse symptoms persist for more than 1 week, or clear up and occur again within a few days rash or other allergic reaction develops keep out of reach of children. if swallowed, get medical help or contact a poison control centre right away.
Do Not Use:
Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product ask a doctor before use if you have liver disease ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning in case of overdose, get medical help or contact a poison control center right away. (1-800-222-1222) quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Warnings for external use only do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth ask a doctor before use on chicken pox on measles when using this product avoid contact with eyes stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur again within a few days 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 if you are allergic to any of the ingredients in the eyes over large areas of the body ask a doctor before use if you have deep or puncture wounds animal bites serious burns stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse symptoms persist for more than 1 week, or clear up and occur again within a few days rash or other allergic reaction develops keep out of reach of children. if swallowed, get medical help or contact a poison control centre right away.
When Using:
When using this product avoid contact with eyes
Dosage and Administration:
Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor
Directions do not use more than directed adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor
Directions adults and children 2 years of age and older: 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 children under 2 years of age: ask a doctor
Stop Use:
Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present these could be signs of a serious condition.
Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur again within a few days
Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse symptoms persist for more than 1 week, or clear up and occur again within a few days rash or other allergic reaction develops
Package Label Principal Display Panel:
Principal display panel - kit package label johnson & johnson ® all-purpose first aid kit outdoors on-the-go at home includes $20 value 5 full-size items cuts & scrapes minor burns itch relief pain relief skin rashes insect bites 140 items see back panel principal display panel - kit package label
Further Questions:
Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Questions? call toll-free 800-524-2624 (english/spanish) or 215-273-8755 (collect)
Questions? call 800-223-0182 or 215-273-8755 (collect)