PROVAULT COOLING ROLL ON- menthol, camphor gel
Sombra Cosmetics Inc

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.

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Provault Cooling Roll on

Active Ingredients

Menthol USP 8%, Camphor USP 2%

Purpose

Purpose
External Analgesic

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

Label

unit Carton

PROVAULT COOLING ROLL ON
menthol, camphor gel

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Sombra Cosmetics Inc (097464309)

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