FIRST AID ANTIBIOTIC PLUS BURN RELIEF- bacitracinzinc,neomycinsulfate,polymxinbsulfate,pramoxinehci ointment 
Trifecta Pharmaceuticals USA LLC

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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Globe First Aid Antibiotic Plus Burn Relief

Active Ingredient

Pramoxine HCI

Purpose Section

External Analgesic

Active Ingredient

Polymyxin B Sulfate

Purpose

First Aid Antibiotic

Active Ingredient

Bacitracin Zinc

Purpose

First Aid Antibiotic

Neomycin Sulfate

Purpose

First Aid Antibiotic

Uses

First Aid to help prevent infection and for the temporary relief of pain or discomfort in minor cuts, scrapes and burns.

Warnings

For external Use Only

Do Not Use

Do Not use

Ask Doctor before use if you have

Stop Use and ask a doctor if

Directions

Adults and children 2 years of age and older:

Children under 2 years old: ask a doctor

Inactive Ingredients

White Petrolatum

Questions

Call 1-888-296-9067

Storage Information

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Fort Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Globe First Aid Antibiotic and Burn Relief 2oz Rev13 082523 CDER

FIRST AID ANTIBIOTIC PLUS BURN RELIEF 
bacitracinzinc,neomycinsulfate,polymxinbsulfate,pramoxinehci ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-138
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-138-021 in 1 BOX09/04/2023
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/04/2023
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 9/2023
Document Id: 048871fe-40a9-4877-e063-6394a90addbd
Set id: 048871e2-c917-292d-e063-6394a90af130
Version: 1
Effective Time: 20230901
 
Trifecta Pharmaceuticals USA LLC