Label: CHAPSTICK CLASSIC SPEARMINT- petrolatum stick
- NDC Code(s): 0573-1912-12, 0573-1912-24, 0573-1912-50
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 30, 2020
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- Active ingredient
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- PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack
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INGREDIENTS AND APPEARANCE
CHAPSTICK CLASSIC SPEARMINT
petrolatum stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-1912 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 450 mg in 1 g Inactive Ingredients Ingredient Name Strength ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CARNAUBA WAX (UNII: R12CBM0EIZ) CETYL ALCOHOL (UNII: 936JST6JCN) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN (UNII: 7EV65EAW6H) LIGHT MINERAL OIL (UNII: N6K5787QVP) MALTOL (UNII: 3A9RD92BS4) LEVOMENTHOL (UNII: BZ1R15MTK7) METHYLPARABEN (UNII: A2I8C7HI9T) OCTYLDODECANOL (UNII: 461N1O614Y) PARAFFIN (UNII: I9O0E3H2ZE) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PROPYLPARABEN (UNII: Z8IX2SC1OH) SACCHARIN (UNII: FST467XS7D) SPEARMINT OIL (UNII: C3M81465G5) WHITE WAX (UNII: 7G1J5DA97F) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color GREEN Score Shape BULLET Size 42mm Flavor SPEARMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-1912-12 1 in 1 BLISTER PACK 08/01/2012 1 4 g in 1 CYLINDER; Type 0: Not a Combination Product 2 NDC:0573-1912-24 1 in 1 BLISTER PACK 08/01/2012 2 4 g in 1 CYLINDER; Type 0: Not a Combination Product 3 NDC:0573-1912-50 4 g in 1 CYLINDER; Type 0: Not a Combination Product 08/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/01/2012 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) Establishment Name Address ID/FEI Business Operations Fareva Richmond, Inc. 969523245 ANALYSIS(0573-1912) , LABEL(0573-1912) , MANUFACTURE(0573-1912) , PACK(0573-1912) , RELABEL(0573-1912) , REPACK(0573-1912)