FIRST AID MAXIMUM STRENGTH BACITRAYCIN PLUS- bacitracin, and pramoxine hcl ointment 
First Aid Research 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.

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First Aid Maximum Strength Bacitraycin Plus Ointment 1oz 49555 (2018)

Active ingredients (each gram contains) Purpose

Bacitracin 500 units.......................................................................................................First Aid Antibiotic

Pramoxine HCI 10 mg..................................................................................................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

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

49555

89884V

FIRST AID MAXIMUM STRENGTH BACITRAYCIN PLUS 
bacitracin, and pramoxine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75983-055
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
METHYLPARABEN (UNII: A2I8C7HI9T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75983-055-281 in 1 CARTON03/01/2018
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/01/2018
Labeler - First Aid Research Corp (089405927)

Revised: 3/2018
Document Id: 6664713c-8be3-38c4-e053-2991aa0a7772
Set id: 6664713c-8be2-38c4-e053-2991aa0a7772
Version: 1
Effective Time: 20180301
 
First Aid Research Corp