Label: CHAPSTICK MEDICATED- camphor, menthol, petrolatum, phenol stick
- NDC Code(s): 0573-0720-12, 0573-0720-51, 0573-0720-70
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) 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 November 9, 2020
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INGREDIENTS AND APPEARANCE
CHAPSTICK MEDICATED
camphor, menthol, petrolatum, phenol stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0720 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 10 mg in 1 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 6 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 410 mg in 1 g PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 5 mg in 1 g Inactive Ingredients Ingredient Name Strength ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB) CARNAUBA WAX (UNII: R12CBM0EIZ) CETYL ALCOHOL (UNII: 936JST6JCN) COCOA BUTTER (UNII: 512OYT1CRR) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN (UNII: 7EV65EAW6H) LIGHT MINERAL OIL (UNII: N6K5787QVP) OCTYLDODECANOL (UNII: 461N1O614Y) OLEYL ALCOHOL (UNII: 172F2WN8DV) PARAFFIN (UNII: I9O0E3H2ZE) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) WHITE WAX (UNII: 7G1J5DA97F) Product Characteristics Color YELLOW Score Shape BULLET (Cylindrical) Size 42mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0720-12 1 in 1 BLISTER PACK 06/10/2018 1 4 g in 1 CYLINDER; Type 0: Not a Combination Product 2 NDC:0573-0720-51 4 g in 1 CYLINDER; Type 0: Not a Combination Product 06/10/2018 3 NDC:0573-0720-70 2 in 1 BLISTER PACK 06/10/2018 3 4 g in 1 CYLINDER; 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 part348 06/10/2018 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)