ABRIDGE  - benzalkonium chloride cream 
Unicep Packaging 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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Drug Facts

Active Ingredient
Benzalkonium Chloride 0.13%



Purpose
Cold Sore/Fever Blister Treatment/First Aid Antiseptic

Uses
For treatment of cold sores/fever blisters on the face or lips
Helps relieve the symptoms of itching, burning and pain associated with cold sores/fever blisters in just one day
Relieves dryness and softens cold sores and fever blisters
First aid to help protect against infection in minor cuts, scrapes, burns, and sores



Warnings

For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or
serious burns, consult a physician.
Allergy Alert: Do not use if you are allergic to any of the ingredients in this product.
When using this product avoid contact with eyes. Use only as directed.
Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.



Uses
For treatment of cold sores/fever blisters on the face or lips
Helps relieve the symptoms of itching, burning and pain associated with cold sores/fever blisters in just one day
Relieves dryness and softens cold sores and fever blisters
First aid to help protect against infection in minor cuts, scrapes, burns, and sores


Directions
Clean the affected area
Apply a small amount of this product to the affected area 1 to 3 times daily
Rub in gently
Wash hands before and after applying cream
Do not share this product with anyone
Children under 12 years of age: ask a doctor



Warnings

For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or
serious burns, consult a physician.
Allergy Alert: Do not use if you are allergic to any of the ingredients in this product.
When using this product avoid contact with eyes. Use only as directed.
Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.




Directions
Clean the affected area
Apply a small amount of this product to the affected area 1 to 3 times daily
Rub in gently
Wash hands before and after applying cream
Do not share this product with anyone
Children under 12 years of age: ask a doctor

Inactive Ingredients
Alcohol, Aloe Barbadensis Leaf Juice, Arginine, Butylparaben, Camphor, Cetearylisononanoate, Dipropylenglycole Dicaprylate-Dicaprate,
Ethylparaben, Eucalyptus Globulus Leaf Oil, Hexyldecanole, Hexyl Decyl Laurate, Menthol,
Methylparaben, Ozokerite, Phenoxyethanol Melaleuca Alternifolia (Tea Tree) Leaf Oil, Poloxamer 407, Propylparaben, Tocopheryl Nicotinate
(Vitamin E), Thymol, Zinc Chloride


Principal Display Panel

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ABRIDGE 
benkalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60747-025
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM ) BENZALKONIUM CHLORIDE.005 g  in 2 g
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX1.04 g  in 2 g
POLOXAMER 407.42 g  in 2 g
ALOE VERA LEAF.07 g  in 2 g
TEA TREE OIL.017 g  in 2 g
CAMPHOR OIL.10 g  in 2 g
THYMOL.052 g  in 2 g
ALPHA-TOCOPHEROL ACETATE.048 g  in 2 g
LEVOMENTHOL.02 g  in 2 g
EUCALYPTOL.017 g  in 2 g
ZINC CHLORIDE.012 g  in 2 g
ARGININE.008 g  in 2 g
ALCOHOL.16 g  in 2 g
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:60747-025-012 g in 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2011

Labeler - Unicep Packaging Inc. (790263909)
Registrant - Unicep Packaging Inc. (790263909)
Establishment
NameAddressID/FEIOperations
Unicep Packaging Inc.790263909manufacture

Revised: 02/2012 Unicep Packaging Inc.