QUALITY CHOICE COLD SORE TREATMENT - benzalkonium chloride cream 
Chain Drug Marketing Association 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


Warnings

Directions


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.

QUALITY CHOICE COLD SORE TREATMENT 
benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-406
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Arginine (UNII: 94ZLA3W45F)  
Butylparaben (UNII: 3QPI1U3FV8)  
Camphor (Synthetic) (UNII: 5TJD82A1ET)  
Cetearyl Isononanoate (UNII: P5O01U99NI)  
Dipropylene Glycol Caprate/Caprylate Diester (UNII: R6G12EY23X)  
Ethylparaben (UNII: 14255EXE39)  
Corymbia Citriodora Leaf Oil (UNII: M63U6N96EB)  
Hexyldecanol (UNII: 151Z7P1317)  
Hexyldecyl Laurate (UNII: 0V595C1P6M)  
Levomenthol (UNII: BZ1R15MTK7)  
Methylparaben (UNII: A2I8C7HI9T)  
Ceresin (UNII: Q1LS2UJO3A)  
Tea Tree Oil (UNII: VIF565UC2G)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Propylparaben (UNII: Z8IX2SC1OH)  
Alpha-Tocopherol (UNII: H4N855PNZ1)  
Thymol (UNII: 3J50XA376E)  
Zinc Chloride (UNII: 86Q357L16B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-406-011 in 1 PACKAGE
12 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2012
Labeler - Chain Drug Marketing Association Inc (011920774)
Registrant - Ranir LLC (364567615)
Establishment
NameAddressID/FEIBusiness Operations
Ranir LLC364567615label

Revised: 4/2012
Document Id: f6636fa7-c50c-4c2b-bc4c-da7f21836a1c
Set id: 538c0292-3139-492a-8662-1155e627af8a
Version: 1
Effective Time: 20120401
 
Chain Drug Marketing Association Inc