First Aid Antibiotic Bacitraycin Plus Maximum Strength: Package Insert and Label Information

FIRST AID ANTIBIOTIC BACITRAYCIN PLUS MAXIMUM STRENGTH- bacitracin and pramoxine hydrochloride ointment
Anicare Pharmaceuticals Pvt. Ltd

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 (each gram contains)

Bacitracin 500 units

Pramoxine HCl 10 mg

Purpose

First Aid Antibiotic

Pain Reliever

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

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

Inactive ingredients

aloe vera leaf, methylparaben, mineral oil, petrolatum, propylparaben, stearyl alcohol

Distributed by:

First Aid Research Corp.

Jupiter, FL 33478

Made in India

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FIRST AID ANTIBIOTIC BACITRAYCIN PLUS MAXIMUM STRENGTH
bacitracin and pramoxine hcl ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47046-163
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
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
METHYLPARABEN
MINERAL OIL
PETROLATUM
PROPYLPARABEN
STEARYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47046-163-02 1 TUBE in 1 CARTON contains a TUBE (47046-163-01)
1 NDC:47046-163-01 28 g in 1 TUBE This package is contained within the CARTON (47046-163-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 02/20/2018
Labeler — Anicare Pharmaceuticals Pvt. Ltd (916837425)
Registrant — Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
Name Address ID/FEI Operations
Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture (47046-163)

Revised: 12/2020 Anicare Pharmaceuticals Pvt. Ltd

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