HyVee Cold Sore Treatment

Dosage form: cream
Ingredients: Benzalkonium Chloride 1.3mg in 1g
Labeler: Hyvee
NDC Code: 42507-406

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.

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. (1-800-222-1222)

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.

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

HYVEE COLD SORE TREATMENT 
benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-406
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride1.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:42507-406-011 TUBE (TUBE) in 1 PACKAGE
12 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2012
Labeler - Hyvee (006925671)
Registrant - Ranir LLC (364567615)
Establishment
NameAddressID/FEIOperations
Ranir LLC364567615label

Revised: 01/2012
 
Hyvee

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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