Label: EXCHANGE SELECT COLD SORE TREATMENT- camphor, menthol, phenol, white petrolatum gel
- NDC Code(s): 55301-412-00
- Packager: Army & Air Force Exchange Service
- 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 February 8, 2021
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- Active ingredients
- Purpose
- Uses
- Warnings
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
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Package/Label Principal Display Panel
Maximum Strength
(Camphor 3.00%, Menthol 1.00%, Phenol 1.50%, White Petrolatum 89.20%
Cold Sore Treatment
Temporary Relief of Pain and Discomfort!
Works on Contact
Applies Clear
With Tea Tree Oil
Paraben Free
Phthalate free
Sulfate Free
Medicated
Cold Sore / Fever Blister Treatment & Skin Protectant
Net Wt 0.07 oz (2 g)
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INGREDIENTS AND APPEARANCE
EXCHANGE SELECT COLD SORE TREATMENT
camphor, menthol, phenol, white petrolatum gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-412 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 EUCALYPTOL (UNII: RV6J6604TK) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) THYMOL (UNII: 3J50XA376E) TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55301-412-00 1 in 1 PACKAGE 11/04/2020 1 2 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 11/04/2020 Labeler - Army & Air Force Exchange Service (001695568)