POMADA DE LA CAMPANA TRIPLE ANTIBIOTIC PAIN RELIEF- bacitracin, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride cream

Pomada De La Campana Triple Antibiotic Pain Relief by

Drug Labeling and Warnings

Pomada De La Campana Triple Antibiotic 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]

ACTIVE INGREDIENT

Active Ingredients                                                                                                                 Purpose

Bacitracin 500 units per gm-------------------------------------------------------------------------First Aid Antibiotic

Neomycin 3.5 mg per gm---------------------------------------------------------------------------First Aid Antibiotic

Polymyxin B 10,000 units per gm------------------------------------------------------------------First Aid Antibiotic

Pramoxine Hydrochoride 10mg---------------------------------------------------------------------First Aid Antibiotic

PURPOSE

Uses

First aid to help prevent infection in and temporarily relieve pain due to minor:

Cuts, Scrapes, Burns

WARNINGS

For external use only

Allergey Alert: Do not use if allergic to any of the ingredients

DO NOT USE

Do not use

in or near the eyes or nose

on large areas of the body

ASK DOCTOR

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

WHEN USING

do not use longer than 1 week

STOP USE

Stop use and ask a doctor if

condition lasts or gets worse

symptoms last more than 7 days or clear up and occur again within a few days

a rash or other allergic reaction occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

INDICATIONS & USAGE

Directions

Adults and children 2 years and older:

clean affected area

apply a small 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 2 years and under: ask a doctor

STORAGE AND HANDLING

Other information

Store at controlled room temperature at 68°-77° (20°-25°)

INACTIVE INGREDIENT

Inactive Ingredient

Liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum

DOSAGE & ADMINISTRATION

Distributed by:

Genomma lab USA Inc.,

Houston, TX, 77027

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POMADA DE LA CAMPANA TRIPLE ANTIBIOTIC PAIN RELIEF 
bacitracin, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	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
PARAFFIN (UNII: I9O0E3H2ZE)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-013-14	1 in 1 CARTON	10/27/2016
1		14 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 final	part333B	06/30/2014

Labeler - Genomma Lab USA, Inc. (832323534)