Label: MENTHOLATUM MEDICATED LIP BALM CHERRY- dimethicone, octinoxate, octisalate ointment
- NDC Code(s): 10742-8893-1, 10742-8893-3
- Packager: The Mentholatum Company
- 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 February 7, 2023
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Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
For external use only
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INGREDIENTS AND APPEARANCE
MENTHOLATUM MEDICATED LIP BALM CHERRY
dimethicone, octinoxate, octisalate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8893 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 10 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) LANOLIN (UNII: 7EV65EAW6H) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) MINERAL OIL (UNII: T5L8T28FGP) CERESIN (UNII: Q1LS2UJO3A) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-8893-1 1 in 1 BLISTER PACK 08/01/2016 1 4.2 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10742-8893-3 3 in 1 BLISTER PACK 10/01/2018 2 4.2 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 final part352 08/01/2016 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-8893)