Label: MAXIMUM STRENGTH COLD SORE TREATMENT- camphor, menthol, phenol, white petrolatum gel
- NDC Code(s): 11673-412-01
- Packager: Target Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 March 4, 2021
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- Active ingredients
- 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.
- Directions
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- Cold Sore Tube card PDP
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH COLD SORE TREATMENT
camphor, menthol, phenol, white petrolatum gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-412 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 30 mg in 1 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 10 mg in 1 g PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 15 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 892 mg in 1 g Inactive Ingredients Ingredient Name Strength THYMOL (UNII: 3J50XA376E) EUCALYPTOL (UNII: RV6J6604TK) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-412-01 2 g in 1 TUBE; Type 0: Not a Combination Product 06/27/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/27/2019 Labeler - Target Corporation (006961700)