PROVAULT COOLING ROLL ON- menthol, camphor gel

Provault Cooling Roll on by

Drug Labeling and Warnings

Provault Cooling Roll on by is a Otc medication manufactured, distributed, or labeled by Sombra Cosmetics Inc, Sombra Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol USP 8%, 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

Aloe Baradensis (Aloe) Leaf Juice, Aqua/Purified Water, Arnica Montana (Arnica) Flower Extract, Cannabidiol (CBD), Chamomilla Recutita (Chamomile) Flower Extract, Gluconolactone, Glycerin (Kosher Vegetable), Hemp Seed Oil, Lonicera Japonica (Honeysuckle) Flower Extract, Mentha Arvensis (mint) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Tocopherol (Natural Vitamin E), Xanthan Gum.

Questions or Comments

Call 866 419 0043

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVAULT COOLING ROLL ON 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-6100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.08 g  in 1 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CANNABIDIOL (UNII: 19GBJ60SN5)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
glycerin (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)
ROSEMARY OIL (UNII: 8LGU7VM393)
CHAMOMILE (UNII: FGL3685T2X)
HEMP (UNII: TD1MUT01Q7)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-6100-1	88.7 g in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/19/2022

Labeler - Sombra Cosmetics Inc (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
Sombra Cosmetics		097464309	manufacture(61577-6100) , label(61577-6100)