Label: EXTRA STRENGTH PAIN RELIEF CREAM- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 82075-415-00, 82075-415-15 - Packager: Sagely Enterprises Inc.
- 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 19, 2021
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- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
Water, Propanediol, Cetyl Alcohol, Caprylic/Capric Triglyceride, Stearyl Alcohol, Glycerin, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Glucoside, Cetearyl Alcohol, Diheptyl Succinate, Xanthan Gum, Boswellia Serrata Resin Extract, Safflower (Carthamus Tinctorius) Seed Oil, Hemp (Cannabis Sativa) Seed Oil, Marula (Sclerocarya Birrea) Seed Oil, Argan (Argania Spinosa) Kernel Oil, Tocopheryl Acetate, Camphor, Peppermint (Mentha Piperita) Oil, Glyceryl Caprylate, Caprylhydroxamic Acid, Sodium Hydroxide
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEF CREAM
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82075-415 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g in 100 g Inactive Ingredients Ingredient Name Strength SAFFLOWER OIL (UNII: 65UEH262IS) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) PEPPERMINT OIL (UNII: AV092KU4JH) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K) SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F) ARGAN OIL (UNII: 4V59G5UW9X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETYL ALCOHOL (UNII: 936JST6JCN) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) CAMPHOR (NATURAL) (UNII: N20HL7Q941) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM HYDROXIDE (UNII: 55X04QC32I) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82075-415-15 1 in 1 CARTON 07/02/2021 1 118 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:82075-415-00 1 in 1 CARTON 11/19/2021 2 88 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 part348 07/02/2021 Labeler - Sagely Enterprises Inc. (117049032) Establishment Name Address ID/FEI Business Operations Verde Cosmetic Labs, LLC 080656433 manufacture(82075-415)