Label: WALGREENS COLD SORE TREATMENT- benzalkonium chloride and camphor (synthetic) cream
- NDC Code(s): 0363-0407-02
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active Ingredient
Benzalkonium Chloride 0.13%
Cold sore/fever blister treatment/first aid antisepticClose
- 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
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.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222Close
- 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 temperatureClose
- 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 chlorideClose
- Questions or Comments?
Call us toll-free at 1-877-242-3234 Monday-Friday, 9 a.m. to 5 p.m. EST.Close
Serious side effects associated with use of this product may be reported to this number.
- INGREDIENTS AND APPEARANCE
WALGREENS COLD SORE TREATMENT
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0407 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 CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 30 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 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)