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

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First Aid Antibiotic Bacitraycin Plus Maximum Strength Ointment

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

Warnings

For external use only.

Do not use

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

Stop use and ask a doctor if

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

Directions

Other information

Inactive ingredients

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

Distributed by:

First Aid Research Corp.

Jupiter, FL 33478

Made in India

image description

FIRST AID ANTIBIOTIC BACITRAYCIN PLUS MAXIMUM STRENGTH 
bacitracin and pramoxine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47046-163
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47046-163-021 in 1 CARTON02/20/2018
1NDC:47046-163-0128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B02/20/2018
Labeler - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(47046-163)

Revised: 12/2020
Document Id: b65eeccf-48e8-6769-e053-2a95a90a1956
Set id: b65ee2ed-b506-7bcf-e053-2995a90ae10a
Version: 1
Effective Time: 20201213
 
Anicare Pharmaceuticals Pvt. Ltd