WALGREENS COLD SORE TREATMENT- benzalkonium chloride and camphor (synthetic) cream 
Walgreens

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%

Camphor 3.0%

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, ethylparaben, eucalyptus globulus leaf oil, hexyl decyl laurate, hexyldecanole, melaleuca alternifolia (tea tree) leaf oil, menthol, methylparaben, ozokerite, phenoxyethanol, poloxamer 407, propylene glycol dicaprylate/dicaprate, 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.

Walgreens Cold Sore Treatment Pump
WALGREENS COLD SORE TREATMENT 
camphor cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0407
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride 1.3 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 30 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Alcohol (UNII: 3K9958V90M)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Arginine (UNII: 94ZLA3W45F)  
Butylparaben (UNII: 3QPI1U3FV8)  
Ceresin (UNII: Q1LS2UJO3A)  
Cetearyl Isononanoate (UNII: P5O01U99NI)  
Corymbia Citriodora Leaf Oil (UNII: M63U6N96EB)  
Dipropylene Glycol Caprate/Caprylate Diester (UNII: R6G12EY23X)  
Ethylparaben (UNII: 14255EXE39)  
Hexyldecanol (UNII: 151Z7P1317)  
Hexyldecyl Laurate (UNII: 0V595C1P6M)  
Levomenthol (UNII: BZ1R15MTK7)  
Methylparaben (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Propylparaben (UNII: Z8IX2SC1OH)  
Tea Tree Oil (UNII: VIF565UC2G)  
Thymol (UNII: 3J50XA376E)  
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)  
Zinc Chloride (UNII: 86Q357L16B)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0363-0407-02 1 in 1 PACKAGE
1 2 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 07/15/2013
Labeler - Walgreens (008965063)
Registrant - Ranir LLC (364567615)
Establishment
Name Address ID/FEI Business Operations
Ranir LLC 364567615 REPACK(0363-0407) , RELABEL(0363-0407)

Revised: 7/2013
Document Id: 70afbecc-f39b-48d7-9839-907a786a8c29
Set id: 70afbecc-f39b-48d7-9839-907a786a8c29
Version: 1
Effective Time: 20130715
 
Walgreens