Provault Cooling Roll on

Manufacturer: Sombra Cosmetics Inc | Sombra Cosmetics
Effective date: 2022-10-19
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:51:05

Label at a glance#

ProductProvault Cooling Roll on

Active ingredientMENTHOL, CAMPHOR (NATURAL)

Label structure10 sections

Indications and uses

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

Dosage and administration

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.

Contacts and useful links#

PhoneLabel contact866 419 0043

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 8%, Camphor USP 2%

Purpose

OTC - PURPOSE SECTION

Purpose
External Analgesic

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Call 866 419 0043

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

unit Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4d7a96d5-8256-4268-9a6c-25ea66d321fe	Product name	1	20180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61577-6100-1	2024-01-30	C162847	48780-1	1030e365-51ce-111a-e063-dadaa90a10e2	Provault Cooling Roll on

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61577-6100-1	Provault Cooling Roll on	88.7 g in 1 BOTTLE	GEL	88.7		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61577-6100	PROVAULT COOLING ROLL ON (MENTHOL, CAMPHOR) GEL [SOMBRA COSMETICS INC]	1	Legacy NDC, 1 package rows	20221020_5197b446-e4b3-40f3-9457-285f4e4b849a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

Provault Cooling Roll on
Menthol, Camphor
WATER
CANNABIDIOL
TOCOPHEROL
ALOE VERA LEAF
GLUCONOLACTONE
glycerin
XANTHAN GUM
ARNICA MONTANA FLOWER WATER
ROSEMARY OIL
CHAMOMILE
HEMP
LONICERA JAPONICA FLOWER
MENTHA ARVENSIS FLOWER OIL
MENTHOL
CAMPHOR (NATURAL)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61577-6100	61577-6100-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
CANNABIDIOL	19GBJ60SN5	IACT
TOCOPHEROL	R0ZB2556P8	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
GLUCONOLACTONE	WQ29KQ9POT	IACT
glycerin	PDC6A3C0OX	IACT
XANTHAN GUM	TTV12P4NEE	IACT
ARNICA MONTANA FLOWER WATER	U7L2JP51PR	IACT
ROSEMARY OIL	8LGU7VM393	IACT
CHAMOMILE	FGL3685T2X	IACT
HEMP	TD1MUT01Q7	IACT
LONICERA JAPONICA FLOWER	4465L2WS4Y	IACT
MENTHA ARVENSIS FLOWER OIL	Q129Z1W6Y2	IACT
MENTHOL	L7T10EIP3A	ACTIB
CAMPHOR (NATURAL)	N20HL7Q941	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2c25ea4f-a456-46eb-8fab-0509facaaa2c			5197b446-e4b3-40f3-9457-285f4e4b849a	2022-10-19	Warnings	Exact identifier spl id: 2c25ea4f-a456-46eb-8fab-0509facaaa2c spl set id: 5197b446-e4b3-40f3-9457-285f4e4b849a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.