FDA.reportPublic FDA data

Provault Muscle Salve

Manufacturer
Sombra Cosmetics Inc
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 Muscle Salve
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 7%, 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

Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea) Butter, Calendula officinalis (Calendula) Flower Extract, Cannabidiol (CBD), Chamomilla Recutita Matricaria (Chamomile) Flower Extract, Citrus Medica Limonum (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Glycerin, (Kosher Vegetable), Hemp Seed Oil, Hydrogenated Cocos Nucilera (Coconut) Oil, Lonicera Japonica (Honeysuckle) Flower Extract, Mentha Avensis (Mint) Leaf Oil.

Questions or Comments

OTC - QUESTIONS SECTION

Call 866 419 0043

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

unit cartonunit carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-6300-12024-01-30C16284748780-11030e365-388e-111a-e063-dadaa90a10e2Provault Muscle Salve

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-6300-1Provault Muscle Salve68 g in 1 JARGEL681

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-6300PROVAULT MUSCLE SALVE (MENTHOL, CAMPHOR) GEL [SOMBRA COSMETICS INC]1Legacy NDC, 1 package rows20221020_d76e9c13-fa4b-48cf-9c90-e119ead75bf2.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-630061577-6300-1

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
NameUNIIKind
SHEA BUTTERK49155WL9YIACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
CARNAUBA WAXR12CBM0EIZIACT
CANNABIDIOL19GBJ60SN5IACT
TOCOPHEROLR0ZB2556P8IACT
JOJOBA OIL724GKU717MIACT
ARNICA MONTANA FLOWER WATERU7L2JP51PRIACT
HEMPTD1MUT01Q7IACT
LEMON OILI9GRO824LLIACT
EUCALYPTUS OIL2R04ONI662IACT
SPEARMINT OILC3M81465G5IACT
ROSEMARY OIL8LGU7VM393IACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
MENTHOLL7T10EIP3AACTIB
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
bf7a39e5-8b80-4482-9d51-27fa4837090fd76e9c13-fa4b-48cf-9c90-e119ead75bf22022-10-19WarningsExact identifier
spl id: bf7a39e5-8b80-4482-9d51-27fa4837090f
spl set id: d76e9c13-fa4b-48cf-9c90-e119ead75bf2

Reported adverse events (FAERS/openFDA)#

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