Label: HOT/COLD MENTHOL 16% ROLL-ON liquid
- NDC Code(s): 0395-9131-97
- Packager: Humco Holding Group, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 2023
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WARNINGS
When using this product: use only as directed. Do not bandage tightly or use with a heating pad. Avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged, broken or irritated skin. If you experience pain, swelling, or blistering of the skin where an OTC topical muscle and joint pain reliever was applied, stop using the product and seek professional attention immediately. These products produce local warmth or coolness.
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INGREDIENTS AND APPEARANCE
HOT/COLD MENTHOL 16% ROLL-ON
hot/cold menthol 16% roll-on liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-9131 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 16 mg in 100 mL Inactive Ingredients Ingredient Name Strength (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) ALCOHOL (UNII: 3K9958V90M) CAPSAICIN (UNII: S07O44R1ZM) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0395-9131-97 74 mL in 1 CONTAINER; Type 0: Not a Combination Product 12/21/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 12/21/2018 Labeler - Humco Holding Group, Inc (825672884) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 label(0395-9131) , pack(0395-9131) , analysis(0395-9131) , manufacture(0395-9131)