Label: RE-LEVE FOOTLUBE PAIN RELIEF- menthol gel
- NDC Code(s): 61577-5042-5
- Packager: SOMBRA COSMETICS 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 28, 2022
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- Active Ingredients
- Purpose
- Keep out of the reach of children
- Uses
- Warnings
- Directions
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Inactive Ingredients
Purified water, Carbomer, Yellow #5 Colorant, Blue #1 Colorant, Hamamelis Viriniana Leaf Extract, Yucca Schidigera Stem/Root Extract, Citrus Grandis (Grapefruit) Seed Extract, Decyl Glucoside, Vegetable Glycerin, Aloe Barbadensis Leaf Juice, Emu Oil, Simmondsia Chinensis (Jojoba) Seed oil, Phenoxyethanol, Germanium oil, Caprylyl Glycol, Sodium Carbonate.
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INGREDIENTS AND APPEARANCE
RE-LEVE FOOTLUBE PAIN RELIEF
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61577-5042 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.03 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) WITCH HAZEL (UNII: 101I4J0U34) YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72) GRAPEFRUIT SEED OIL (UNII: 598D944HOL) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) EMU OIL (UNII: 344821WD61) JOJOBA OIL (UNII: 724GKU717M) PHENOXYETHANOL (UNII: HIE492ZZ3T) GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61577-5042-5 118 g in 1 TUBE; Type 0: Not a Combination Product 11/28/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/28/2022 Labeler - SOMBRA COSMETICS INC. (097464309) Establishment Name Address ID/FEI Business Operations SOMBRA COSMETICS INC. 097464309 manufacture(61577-5042) , label(61577-5042)