Label: SOMBRA WARM THERAPY- menthol camphor gel
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NDC Code(s):
61577-4020-1,
61577-4020-2,
61577-4020-3,
61577-4020-4, view more61577-4020-5
- 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 March 10, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep out of reach of children
- Uses
- Warnings
- Directions
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Inactive Ingredients
aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus aurantium dulcis (orange) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl glycol, capsicum annuum fruit extract
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOMBRA WARM THERAPY
menthol camphor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61577-4020 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 CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.03 g in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) WATER (UNII: 059QF0KO0R) CAPSAICIN (UNII: S07O44R1ZM) GRAPEFRUIT SEED OIL (UNII: 598D944HOL) GREEN TEA LEAF (UNII: W2ZU1RY8B0) FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY) GLYCERIN (UNII: PDC6A3C0OX) WITCH HAZEL (UNII: 101I4J0U34) YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT) ORANGE PEEL (UNII: TI9T76XD44) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61577-4020-1 3628.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/10/2023 2 NDC:61577-4020-2 907.2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/10/2023 3 NDC:61577-4020-3 226.8 g in 1 JAR; Type 0: Not a Combination Product 03/10/2023 4 NDC:61577-4020-4 113.4 g in 1 JAR; Type 0: Not a Combination Product 03/10/2023 5 NDC:61577-4020-5 85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/10/2023 Labeler - SOMBRA COSMETICS INC. (097464309) Establishment Name Address ID/FEI Business Operations SOMBRA COSMETICS INC. 097464309 manufacture(61577-4020) , label(61577-4020)