FAMILY CARE BACITRACIN: Package Insert and Label Information

FAMILY CARE BACITRACIN — bacitracin 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 ingredients (each gram contains) Purpose

Bacitracin 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

  • in the eyes
  • if you are allergic to any of the ingredients
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

  • the condition persists or gets worse
  • a rash or other allergic reaction develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

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 at 15o to 25o C (59o to 77o F)
  • Lot No. and Exp. Date: see box or see crimp of tube

Inactive ingredients

aloe vera gel, light mineral oil, white petrolatum

Distributed By

UNITED EXCHANGE CORP.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

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FAMILY CARE BACITRACIN
bacitracin ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN (BACITRACIN) BACITRACIN 500 [USP’U] in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
LIGHT MINERAL OIL
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65923-004-14 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 14 g in 1 TUBE This package is contained within the CARTON (65923-004-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 03/01/2012
Labeler — UNITED EXCHANGE CORP. (840130579)

Revised: 03/2012 UNITED EXCHANGE CORP.

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