FDA.reportPublic FDA data

Provault Muscle Cream CBD

Manufacturer
Sombra Cosmetics Inc
Effective date
2022-10-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:51:05

Label at a glance#

ProductProvault Muscle Cream CBD
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure9 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.

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

Alchemilla Vulgaris (Lady's Mantle) Extract, Allantoin, Aloe Barbadensis (Aloe) Leaf Juice, Aqua/Purified Water, Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea) Butter, Cannabidiol (CBD), Caprylic/Capric Triglyceride, Cetearyl Glucoside, Cetyl Alcohol, Chamomilla Recutita Matricaria (Chamomile) Flower Extract, Citrus medica Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Gluconolactone, Glycerin (Kosher Vegetable), GLyceryl Sterate SE, Hemp Seed Oil, Lonicera Japonica (Honeysuckle) Flower Extract, Mentha Arvensis (mint) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Stearyl Alcohol, Tocopherol (Natural Vitamin E), Xanthan Gum.

Questions or Comments

OTC - QUESTIONS SECTION

Call 866 419 0043

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-6200-12024-01-30C16284748780-11030e365-4f6c-111a-e063-dadaa90a10e2Provault Muscle Cream CBD

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-6200-1Provault Muscle Cream CBD88.7 g in 1 TUBECREAM88.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-6200PROVAULT MUSCLE CREAM CBD (MENTHOL, CAMPHOR) CREAM [SOMBRA COSMETICS INC]1Legacy NDC, 1 package rows20221019_e8fafc9a-e114-47f9-b9b6-2a84d95f34ff.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-620061577-6200-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CANNABIDIOL19GBJ60SN5IACT
TOCOPHEROLR0ZB2556P8IACT
XANTHAN GUMTTV12P4NEEIACT
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
CETYL ALCOHOL936JST6JCNIACT
OLIVE OIL6UYK2W1W1EIACT
SHEA BUTTERK49155WL9YIACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLUCONOLACTONEWQ29KQ9POTIACT
ROSEMARY OIL8LGU7VM393IACT
LEMON OILI9GRO824LLIACT
CHAMOMILEFGL3685T2XIACT
EUCALYPTUS OIL2R04ONI662IACT
hempTD1MUT01Q7IACT
MENTHA ARVENSIS FLOWER OILQ129Z1W6Y2IACT
ARNICA MONTANA FLOWER WATERU7L2JP51PRIACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
MENTHOLL7T10EIP3AACTIB
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDEU73D397055IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8baac333-2c04-4f6e-ae09-d9d447a0a7c6e8fafc9a-e114-47f9-b9b6-2a84d95f34ff2022-10-18WarningsExact identifier
spl id: 8baac333-2c04-4f6e-ae09-d9d447a0a7c6
spl set id: e8fafc9a-e114-47f9-b9b6-2a84d95f34ff

Reported adverse events (FAERS/openFDA)#

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