PROVAULT DRYSPRAY CBD PAIN RELIEF- menthol, camphor spray

Provault DrySpray CBD Pain Relief by

Drug Labeling and Warnings

Provault DrySpray CBD Pain Relief by is a Otc medication manufactured, distributed, or labeled by Sombra Cosmetics Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol USP 9%, Camphor USP 2%

Purpose

Purpose
External Analgesic

Keep out of reach of children

Keep out of reach of children

Uses

Temporary relief of monor aches and pains of muscles and joints associated with strains, bruises and sprains.

Warnings

​For external use only.​

Directions

Apply to affected area not more than 3 to 4 times daily. After each application, wash hands with soap and water (unless applying to hands). Children under the age of 18, consult a doctor before use.

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

Call 866 419 0043

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVAULT DRYSPRAY CBD PAIN RELIEF 
menthol, camphor spray

Product 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)