Label: PROVAULT DRYSPRAY CBD PAIN RELIEF- menthol, camphor spray
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Contains inactivated NDC Code(s)
NDC Code(s): 61577-6000-1 - 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 October 18, 2022
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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
Aqua/Purified water, Arnica Montana (arnica) Flower Extract, Cannabidiol (CBD), Capsicum Frutescens (Chili Pepper) Friut Extract, Chamomilla Recutita Matricaria (Chamomile) Flower, Citrus medica Limonum (Lemon) Peel Oil, Ethanol Denatured (Ethyl Alcohol), Eucalyptus Globulus Leaf Oil, Glycerin (Kosher Vegetable), Mentha Avensis (Mint) Leaf Oil, Metyl Nicotinate, Rosmarinus Officinalis (Rosemary) Leaf Oil, Tocopherol (Natural Vitamin E).
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROVAULT DRYSPRAY CBD PAIN RELIEF
menthol, camphor sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61577-6000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .09 g in 1 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) .02 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CANNABIDIOL (UNII: 19GBJ60SN5) CAPSAICIN (UNII: S07O44R1ZM) TOCOPHEROL (UNII: R0ZB2556P8) ROSEMARY OIL (UNII: 8LGU7VM393) LEMON OIL (UNII: I9GRO824LL) CHAMOMILE (UNII: FGL3685T2X) ALCOHOL (UNII: 3K9958V90M) EUCALYPTUS OIL (UNII: 2R04ONI662) MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2) ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR) METHYL NICOTINATE (UNII: 7B1AVU9DJN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61577-6000-1 88.7 g in 1 BOTTLE; Type 0: Not a Combination Product 10/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/18/2022 Labeler - Sombra Cosmetics Inc (097464309) Establishment Name Address ID/FEI Business Operations Sombra Cosmetics Inc 097464309 manufacture(61577-6000) , label(61577-6000)