FAMILY CARE TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin neomycin sulfate polymyxin b sulfate pramoxine hydrochloride ointment 
United Exchange Corp.

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 (in each gram)                                                   Purpose

Bacitracin 500 units....................................................................... First aid antibiotic

Neomycin sulfate 3.5 mg................................................................ First aid antibiotic

Polymyxin B sulfate 10,000 units...................................................... First aid antibiotic

Pramoxine hydrochloride 10mg........................................................ First aid antibiotic

Uses

first aid to help prevent infection and for temporarily relief of pain or discomfort in minor:

Warnings

For external use only

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children

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

Directions

Other information

Inactive ingredients

ethanol, liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos CA, 90703 USA

Made in Korea

image description

FAMILY CARE TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
bacitracin neomycin sulfate polymyxin b sulfate pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-523
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
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
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
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:65923-523-141 in 1 CARTON09/15/2016
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 finalpart333B11/24/2014
Labeler - United Exchange Corp. (840130579)
Registrant - United Exchange Corp. (840130579)

Revised: 9/2016
Document Id: 3b3b58be-a652-42f1-ba72-1ac6225c4d2d
Set id: 1c44e5c4-fe86-4a97-882e-29e03838b624
Version: 2
Effective Time: 20160915
 
United Exchange Corp.