Label: FAMILY WELLNESS ORIGINAL- family wellness bacitracin, neomycin, polymyxin b ointment
- NDC Code(s): 69396-041-01
- Packager: Trifecta Pharmaceuticals USA LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 17, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (each gram contains)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
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 ingredients.
Ask a doctor before use if you have
● deep or puncture wounds ● animal bites ● serious burns.
Stop use and ask a doctor if ● condition persists or gets worse
● you need to use longer than 1 week
● a rash or other allergic reaction develops
- Directions
- INACTIVE INGREDIENT
- Other information
- QUESTIONS
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SPL UNCLASSIFIED SECTION
DISTRIBUTED BY: MIDWOOD BRANDS, LLC.
500 Volvo Parkway, Chesapeake, VA. 23320
NOT 100% 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 Corporation, owner of the registered trademark Neosporin®
- Packaging
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INGREDIENTS AND APPEARANCE
FAMILY WELLNESS ORIGINAL
family wellness bacitracin, neomycin, polymyxin b ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-041 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [USP'U] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) SQUALANE (UNII: GW89575KF9) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) CETYL ALCOHOL (UNII: 936JST6JCN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-041-01 1 in 1 BOX 09/23/2019 1 28.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 08/30/2019 Labeler - Trifecta Pharmaceuticals USA LLC. (079424163)
