Label: PAIN RELIEF ROLL-ON- menthol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 82075-420-05, 82075-420-20 - Packager: Sagely Enterprises Inc.
- 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 November 19, 2021
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- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
Water, Propanediol, Capryloyl Glycerin/Sebacic Acid Copolymer, Coco-Caprylate, Glyceryl Stearate, Glyceryl Stearate Citrate, Diheptyl Succinate, Glycerin, Lauryl Glucoside, Polyglyceryl-2 Dipolyhydroxystearate, Microcrystalline Cellulose, Cellulose Gum, Phytic Acid, Leuconostoc/Radish Root Ferment Filtrate, Boswellia Serrata Resin Extract, Polyglyceryl-6 Caprylate, Polyglyceryl-4 Caprate, Polyglyceryl-4 Cocoate, Polyglyceryl-6 Ricinoleate, Polyglyceryl-4 Laurate/Sebacate, Polyglyceryl-6 Caprylate/Caprate, Camphor, Arnica Montana Flower Extract, Aloe Barbadensis Leaf Extract, Xanthan Gum, Lavender (Lavandula Hybrida) Oil, Peppermint (Mentha Piperita) Oil, Caprylyl Glyceryl Ether, Caprylhydroxamic Acid
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INGREDIENTS AND APPEARANCE
PAIN RELIEF ROLL-ON
menthol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82075-420 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 LAVENDER OIL (UNII: ZBP1YXW0H8) PEPPERMINT OIL (UNII: AV092KU4JH) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) ARNICA MONTANA (UNII: O80TY208ZW) GLYCERIN (UNII: PDC6A3C0OX) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K) PROPANEDIOL (UNII: 5965N8W85T) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYGLYCERYL-6 CAPRYLATE (UNII: DGV8R54VG7) POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885) POLYGLYCERYL-6 RICINOLEATE (UNII: 8X57R183N7) CAMPHOR (NATURAL) (UNII: N20HL7Q941) ALOE VERA LEAF (UNII: ZY81Z83H0X) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) COCO-CAPRYLATE (UNII: 4828G836N6) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) FYTIC ACID (UNII: 7IGF0S7R8I) CAPRYLYL GLYCERYL ETHER (UNII: MI97BW74XZ) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82075-420-20 1 in 1 CARTON 07/02/2021 1 60 g in 1 CYLINDER; Type 0: Not a Combination Product 2 NDC:82075-420-05 1 in 1 CARTON 11/19/2021 2 51 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 07/02/2021 Labeler - Sagely Enterprises Inc. (117049032) Establishment Name Address ID/FEI Business Operations Verde Cosmetic Labs, LLC 080656433 manufacture(82075-420)