Label: RELIEVEIT FOOTSPRAY TOPICAL ANALGESIC- menthol 8% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 58133-956-01, 58133-956-02 - Packager: Cosmetic Specialty labs, 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 March 13, 2020
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- Inactive ingredients
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INGREDIENTS AND APPEARANCE
RELIEVEIT FOOTSPRAY TOPICAL ANALGESIC
menthol 8% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-956 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.2 mg in 15 mL Inactive Ingredients Ingredient Name Strength METHYL SALICYLATE (UNII: LAV5U5022Y) CYCLOMETHICONE (UNII: NMQ347994Z) BIS-ETHOXYDIGLYCOL CYCLOHEXANE 1,4-DICARBOXYLATE (UNII: R6MU0U9L45) HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) LEMON OIL (UNII: I9GRO824LL) EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW) PEPPERMINT OIL (UNII: AV092KU4JH) TEA TREE OIL (UNII: VIF565UC2G) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) 1-(3-AMINO-4-HYDROXYPHENYL)-2-((2-(4-METHOXYPHENYL)-1-METHYLETHYL)AMINO)ETHANOL (UNII: GJY78AX70Q) PINUS RESINOSA WHOLE (UNII: AS8B4M6X9N) EUCALYPTUS OIL (UNII: 2R04ONI662) PROPYLENE GLYCOL 1-ALLYL ETHER (UNII: QRB8092KPK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-956-01 30 mL in 1 CARTON; Type 0: Not a Combination Product 03/13/2020 2 NDC:58133-956-02 30 mL in 1 CARTON; Type 0: Not a Combination Product 03/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/13/2020 Labeler - Cosmetic Specialty labs, Inc. (032973000) Registrant - Cosmetic Specialty labs, Inc. (032973000) Establishment Name Address ID/FEI Business Operations Cosmetic Specialty labs, Inc. 032973000 manufacture(58133-956)