FIRST AID ANTIBIOTIC PLUS BURN RELIEF- bacitracinzinc,neomycinsulfate,polymxinbsulfate,pramoxinehci ointment

First Aid Antibiotic plus Burn Relief by

Drug Labeling and Warnings

First Aid Antibiotic plus Burn Relief by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

ACTIVE INGREDIENT

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

• In the eyes
• Over large areas of the body
• If you are allergic to any of the ingredients

Ask Doctor before use if you have

• Deep or puncture wounds
• Animal Bites
• Serious Burns

Stop Use and ask a doctor if

• Condition persists or gets worse
• You need to use longer than 1 week
• A rash or other allergic reaction develops
• symptoms persist for more than 1 week or clear up and occur again within a few days

Directions

Adults and children 2 years of age and older:

• Clean the affected area and dry thoroughly.
• Apply a small amount of this product , an mount equal to the surgace area of the tip of a finger) on the area 1 to 3 times daily
• May be covered with a sterile bandage

Children under 2 years old: ask a doctor

Inactive Ingredients

White Petrolatum

Questions

Call 1-888-296-9067

Storage Information

• Store at 20° to 25°C (68° to 77°F).
• See carton or tube crimp for lot number and expiration date

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRST AID ANTIBIOTIC PLUS BURN RELIEF 
bacitracinzinc,neomycinsulfate,polymxinbsulfate,pramoxinehci ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-138
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-138-02	1 in 1 BOX	09/04/2023
1		57 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 Drug	M004	09/04/2023

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)