Family Care First Aid: Package Insert and Label Information

FAMILY CARE FIRST AID- bacitracin zinc ointment
United Exchange Corp.

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 (in each gram) Purpose

Bacitracin Zinc 500 units……………………………………….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 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
  • rash or other allergic reaction develops

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • clean the affected area
  • apply a small amount of this product (an amount 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 at room temperature 20-25°C (68-77°F)

Inactive ingredients

aloe vera leaf extract, ethyl alcohol, light mineral oil, methylparaben, petrolatum stearyl alcohol

Distributed by: United Exchange Corp.

Cypress, CA 90630 USA

Made in China

496A
(click image for full-size original)

FAMILY CARE FIRST AID
bacitracin zinc ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-491
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC 500 [USP’U] in 1 g
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN
STEARYL ALCOHOL
ALCOHOL
PETROLATUM
ALOE VERA LEAF
LIGHT MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65923-491-33 1 TUBE in 1 CARTON contains a TUBE
1 9.35 g in 1 TUBE This package is contained within the CARTON (65923-491-33)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 05/17/2022
Labeler — United Exchange Corp. (840130579)

Revised: 05/2022 United Exchange Corp.

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