TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF by

Drug Labeling and Warnings

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by GENOMMA LAB USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each gram)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine HCl 10 mg	External analgesic

Uses

first aid to help prevent infection and for the temporary relief of pain in minor:

• cuts
• scrapes
• burns

Warnings

For external use only.

Do not use

• if you are allergic to any of the ingredients
• in the eyes
• over large areas of the body

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if

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

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

Directions

• adults and children 2 years of age and older:
  • 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
• children under 2 years of age: ask a doctor

Other information

• store at 20° to 25°C (68° to 77°F)
• to open: unscrew cap, pull tab to remove foil seal
• see carton or tube crimp for lot number and expiration date

Inactive ingredient

white petrolatum

Questions?

Call toll free 1-877-994-3666Monday to Friday 8am to 6pm, Central time

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Distributed by:
Genomma Lab USA Inc.
Houston, TX 77098

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

cicatricure ®

OPEN WOUND

FOR MINOR CUTS, SCRAPES AND BURNS

PAIN, ITCH & SCAR

• Triple Antibiotic Ointment
• Up to 24-Hour Infection Protection
• Maximum Strength: Infection Protection,
  Pain & Itch Relief
• Helps Healing Wounds, Minimizing
  the Appearance of Scars**

FIRST AID ANTIBIOTIC
PAIN RELIEVING OINTMENT

Bacitracin Zinc – Neomycin Sulfate – Polyximin B Sulfate – Pramoxine HCl

*Based on published studies. For best results use sterile bandage or gauze.
**Preventing infection helps minimize appearance of scars.

NET WT.
1 oz (28.4 g)

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-202
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-202-01	1 in 1 CARTON	12/21/2023
1		28.4 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	12/21/2023

Labeler - GENOMMA LAB USA, INC. (832323534)