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Family wellness first aid antibiotic - Prescription Drug Labeling

Product NDC Code 69396-037
Drug Name

Family wellness first aid antibiotic

Type Brand
Active Ingredients
Polymyxin b sulfate 10000 [usp'u]/g
Bacitracin zinc 500 [usp'u]/g
Dosage Form OINTMENT
RxCUI drug identifier 308512
Application Number part333B
Labeler Name Trifecta Pharmaceuticals USA, LLC
Package NDC Code Description
69396-037-04 1 tube in 1 box (69396-037-04) > 14.2 g in 1 tube
69396-037-05 1 tube in 1 box (69396-037-05) > 15 g in 1 tube

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Bacitracin 500 Units Active Ingredient Polymyxin B

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Mineral Oil, White Petrolatum

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses First aid to help prevent infection in minor cuts scrapes burns


Information about the drug product’s indications for use.
Purpose First Aid Antibiotic Purpose First Aid Antibiotic

Spl product data elements

Usually a list of ingredients in a drug product.
Family Wellness First Aid Antibiotic Family Wellness bacitracin zinc, polymyxin B sulfate MINERAL OIL PETROLATUM POLYMYXIN B SULFATE POLYMYXIN B BACITRACIN ZINC BACITRACIN

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
FD Double Antibiotic

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Other Information Store between 20° to 25°C (68° to 77°F)

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
If swallowed, get medical help or contact a Poison Control Center immediately.


A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or Comments? Call 1-888-296-9067 Weekdays 9AM to 4PM EST DISTRIBUTED BY: MIDWOOD BRANDS, LLC. 500 Volvo Parkway, Chesapeake, VA. 23320 NOT SATISFIED? Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange. This Product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, owner of the registered trademark Polysporin® MADE IN CHINA

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask doctor if: You need to use longer than 1 week Condition persists or gets worse rash or other allergic reaction develops


Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 puncture wounds animal bites serious burns

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API