Label: WALGREENS COLD SORE TREATMENT- camphor cream
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-0407-02 - Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated July 15, 2013
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- Active Ingredient
- Purpose
- Uses
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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.
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- Directions
- Other Information
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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
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INGREDIENTS AND APPEARANCE
WALGREENS COLD SORE TREATMENT
camphor creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0407 Route of Administration TOPICAL 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)