Healthy Accents Cold Sore Treatment

Dosage form: cream
Ingredients: Benzalkonium Chloride 1.3mg in 1g, CAMPHOR (SYNTHETIC) 30mg in 1g
Labeler: DZA Brands LLC
NDC Code: 55316-407

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 ingredients

Benzalkonium Chloride 0.13%

Camphor 3%

Purpose

Cold sore/fever blister treatment/first aid antiseptic

Uses
for treatment of cold sores/fever blisters on the face or lips
temporarily relieves the symptoms of itching and pain associated with cold sores/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 at 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
may be covered with a sterile bandage
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, cetearyl isononanoate, dipropylene glycol dicaprylate/dicaprate, ethylparaben, eucalyptus globulus leaf oil, hexyl decyl laurate, hexyldecanole, melaleuca alternifolia (tea tree) leaf oil, menthol, methylparaben, ozokerite, phenoxyethanol, poloxamer 407, propylparaben, thymol, tocopheryl nicotinate (vitamin e), 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.

HEALTHY ACCENTS COLD SORE TREATMENT 
camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-407
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride1.3 mg  in 1 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Aloe Vera Leaf 
Arginine 
Butylparaben 
Ceresin 
Cetearyl Isononanoate 
Corymbia Citriodora Leaf Oil 
Dipropylene Glycol Caprate/Caprylate Diester 
Ethylparaben 
Hexyldecanol 
Hexyldecyl Laurate 
Levomenthol 
Methylparaben 
PHENOXYETHANOL 
Poloxamer 407 
Propylparaben 
Tea Tree Oil 
Thymol 
TOCOPHERYL NICOTINATE, D-.ALPHA. 
Zinc Chloride 
Packaging
#Item CodePackage Description
1NDC:55316-407-011 TUBE in 1 PACKAGE
12 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/30/2013
Labeler - DZA Brands LLC (090322194)
Registrant - Ranir LLC (364567615)
Establishment
NameAddressID/FEIOperations
Ranir LLC364567615REPACK(55316-407), RELABEL(55316-407)

Revised: 04/2013
 
DZA Brands LLC

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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