FIRST AID ANTIBIOTIC BACITRAYCIN PLUS MAXIMUM STRENGTH- bacitracin and pramoxine hcl ointment

First Aid Antibiotic Bacitraycin Plus Maximum Strength by

Drug Labeling and Warnings

First Aid Antibiotic Bacitraycin Plus Maximum Strength by is a Otc medication manufactured, distributed, or labeled by Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (each gram contains)                                                                        

Bacitracin             500 units

Pramoxine HCl     10 mg

PURPOSE

Purpose

First Aid Antibiotic

Pain Reliever

INDICATIONS & USAGE

Uses

first aid to help prevent infection in

• minor cuts
• scrapes
• burns

WARNINGS

Warnings

For external use only.

DO NOT USE

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 DOCTOR

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

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

Distributed by:

First Aid Research Corp.

Jupiter, FL 33478

Made in India

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47046-163-02	1 in 1 CARTON	02/20/2018
1	NDC: 47046-163-01	28 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	02/20/2018

Labeler - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(47046-163)