Label: RE-LEVE- menthol gel
- NDC Code(s): 61577-3242-4, 61577-3242-5
- Packager: SOMBRA COSMETICS
- 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 8, 2023
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- Active Ingredients
- Purpose
- Keep out of reach of children
- Uses
- Warnings
- Directions
- Inactive Ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RE-LEVE
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61577-3242 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.06 g in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) WATER (UNII: 059QF0KO0R) CITRUS MAXIMA SEED (UNII: 083X55C543) GREEN TEA LEAF (UNII: W2ZU1RY8B0) FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13) SODIUM CARBONATE (UNII: 45P3261C7T) GLYCERIN (UNII: PDC6A3C0OX) HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT) LEMON OIL (UNII: I9GRO824LL) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61577-3242-4 113.6 g in 1 JAR; Type 0: Not a Combination Product 03/08/2023 2 NDC:61577-3242-5 113.6 g in 1 TUBE; Type 0: Not a Combination Product 03/08/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/08/2023 Labeler - SOMBRA COSMETICS (097464309) Establishment Name Address ID/FEI Business Operations SOMBRA COSMETICS 097464309 manufacture(61577-3242) , label(61577-3242)