POMADA DE LA CAMPANA TRIPLE ANTIBIOTIC PAIN RELIEF- bacitracin, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride cream 
Genomma Lab USA, Inc.

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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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

Uses

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

Cuts, Scrapes, Burns

For external use only

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

Do not use

in or near the eyes or nose

on large areas of the body

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

do not use longer than 1 week

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

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

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

Other information

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

Inactive Ingredient

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

Distributed by:

Genomma lab USA Inc.,

Houston, TX, 77027

Made in Korea

image description

POMADA DE LA CAMPANA TRIPLE ANTIBIOTIC PAIN RELIEF 
bacitracin, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN (UNII: I9O0E3H2ZE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-013-141 in 1 CARTON10/27/2016
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B06/30/2014
Labeler - Genomma Lab USA, Inc. (832323534)

Revised: 10/2016
Document Id: d9f65879-a059-4fe1-afd7-1b119f735657
Set id: f3d37827-590c-495a-8ac1-a17a12f7616c
Version: 3
Effective Time: 20161027
 
Genomma Lab USA, Inc.