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Name:Abridge Cold Sore Treatment
Manufacturer:Ranir Llc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ABRIDGE COLD SORE TREATMENT  - benzalkonium chloride cream 
Ranir LLC

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.

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

Other Information

Store at room temperature

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

Questions or Comments?

Call us toll-free at 1-877-242-3234 Monday-Friday, 9 a.m. to 5 p.m. EST.
Serious side effects associated with use of this product may be reported to this number.

image of carton label

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


ABRIDGE COLD SORE TREATMENT 
benzalkonium chloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66923-406
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride 1.3 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Alcohol  
Aloe Vera Leaf  
Arginine  
Butylparaben  
Camphor (Synthetic)  
Cetearyl Isononanoate  
Dipropylene Glycol Caprate/Caprylate Diester  
Ethylparaben  
Corymbia Citriodora Leaf Oil  
Hexyldecanol  
Hexyldecyl Laurate  
Levomenthol  
Methylparaben  
Ceresin  
Tea Tree Oil  
Poloxamer 407  
Propylparaben  
Alpha-Tocopherol  
Thymol  
Zinc Chloride  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66923-406-01 1 TUBE ( TUBE) in 1 PACKAGE contains a TUBE
1 2 g in 1 TUBE This package is contained within the PACKAGE (66923-406-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/31/2011

Labeler - Ranir LLC (364567615)

Revised: 04/2011 Ranir LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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