Label: SNAP CRACK NATURAL PAIN RELIEVING GEL- menthol camphor gel
- NDC Code(s): 61577-5310-1, 61577-5310-2
- Packager: Sombra Cosmetics 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 December 28, 2021
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- Active Ingredients
- Purpose
- Keep out of reach of children
- Uses
- Warnings
- Directions
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Inactive Ingredients
Aloe Baradensis Leaf Juice, Camillia Sinensis (Green Tea) Leaf Extract, Caprylyl Glycol, Capsicum Annuum Fruit Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Grandis (Grapefruit) Seed Extract, Decyl Glucoside, Glycerin, Hamamelis Viginiana (Witch Hazel) Leaf Extract, Phenoxyethanol, Purified Water, Rose Damascena Flower Water, Sodium Carbonate, Filipendula Ulmaris (Queen of the Prairie) Flower Extract, Yucca Schidigera Root Extract.
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INGREDIENTS AND APPEARANCE
SNAP CRACK NATURAL PAIN RELIEVING GEL
menthol camphor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61577-5310 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .03 g in 1 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) .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) SODIUM CARBONATE (UNII: 45P3261C7T) 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:61577-5310-1 113.4 g in 1 JAR; Type 0: Not a Combination Product 12/28/2021 2 NDC:61577-5310-2 3544 g in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/28/2021 Labeler - Sombra Cosmetics INC (097464309) Establishment Name Address ID/FEI Business Operations Sombra Cosmetic INC 097464309 manufacture(61577-5310) , label(61577-5310)