Family Wellness First Aid Antibiotic: Package Insert and Label Information

FAMILY WELLNESS FIRST AID ANTIBIOTIC- polymyxin b sulfate and bacitracin zinc ointment
Trifecta Pharmaceuticals USA, LLC

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.

Active Ingredient

Bacitracin 500 Units

Purpose

First Aid Antibiotic

Active Ingredient

Polymyxin B

Purpose

First Aid Antibiotic

Uses

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

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

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

If swallowed, get medical help or contact a Poison Control Center immediately.

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

Other Information

Store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

Mineral Oil, White Petrolatum

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

FD Double Antibiotic
(click image for full-size original)

FAMILY WELLNESS FIRST AID ANTIBIOTIC
family wellness bacitracin zinc, polymyxin b sulfate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-037
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 10000 [USP'U] in 1 g
BACITRACIN ZINC (BACITRACIN) BACITRACIN 500 [USP'U] in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69396-037-05 1 TUBE in 1 BOX contains a TUBE
1 15 g in 1 TUBE This package is contained within the BOX (69396-037-05)
2 NDC:69396-037-04 1 TUBE in 1 BOX contains a TUBE
2 14.2 g in 1 TUBE This package is contained within the BOX (69396-037-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 08/29/2019
Labeler — Trifecta Pharmaceuticals USA, LLC (079424163)

Revised: 01/2020 Trifecta Pharmaceuticals USA, LLC

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