Label: MAXIMUM STRENGTH COLD SORE TREATMENT gel
- NDC Code(s): 72476-412-01
- Packager: Retail Business Services, LLC
- 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 December 9, 2021
If you are a consumer or patient please visit this version.
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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
- Other information
- Inactive ingredients
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Principal Display Panel
CAREone®
Maximum Strength
Camphor 3.00%, Menthol 1.00%, Phenol 1.50%, White Petrolatum 89.20%
COLD SORE TREATMENT
Cold Sore/Fever Blister Treatment & Skin Protectant
New & Improved
TEMPORARY RELIEF OF PAIN & DISCOMFORT
Paraben Free
With Tea Tree Oil
Medicated
Phthalate Free
Sulfate Free
Works on Contact
Applied Clear
OUR PHARMACIST RECOMMENDED
NET WT 0.07 oz (2.0 g)
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH COLD SORE TREATMENT
maximum strength cold sore treatment gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-412 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 892 mg in 1 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 30 mg in 1 g PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 15 mg in 1 g Inactive Ingredients Ingredient Name Strength TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C) THYMOL (UNII: 3J50XA376E) EUCALYPTOL (UNII: RV6J6604TK) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72476-412-01 2 g in 1 TUBE; Type 0: Not a Combination Product 02/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/01/2020 Labeler - Retail Business Services, LLC (967989935)