FDA.reportPublic FDA data

Sombra Max

Manufacturer
Sombra Cosmetics Inc.
Effective date
2025-10-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:30:06

Label at a glance#

ProductSombra Max
Active ingredientMENTHOL GLUCURONIDE, HISTAMINE DIHYDROCHLORIDE, CAMPHOR (SYNTHETIC), CAPSAICIN, METHYL SALICYLATE
Label structure9 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains

Dosage and administration

Directions: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients Section OTC

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 12%

Menthol USP 6%

Camphor USP 3%

Capsaicin 0.025%

Histamine Dihydrochloride 0.025%

Purpose

OTC - PURPOSE SECTION

Purpose

External Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains

Warnings

WARNINGS SECTION

For external use only. Do not use if allergic to salicylates (including aspirin), on wounds or damaged skin or with a heat source. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children, if swallowed get medical help or contact a Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aloe Barbadensis Leaf Extract, Carbomer, Cetearyl Alcohol, Cetyl Esters, Caprylyl Glycol, Glycerin, Phenoxyethanol, Polysorbate 60, Purified Water, Sodium Carbonate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Yucca Schidigera Stem Extract.

Questions

OTC - QUESTIONS SECTION

1-800-225-3963

Sombra Max Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sombra Max 4oz label PROOF 9.29.25.jpgSombra Max 4oz label PROOF 9.29.25.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-3440-1Sombra Max1 g in 1 CONTAINERCREAM11
61577-3440-2Sombra Max1 g in 1 PACKETCREAM11

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-344061577-3440-1, 61577-3440-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ESTERSD072FFP9GUIACT
MENTHOL GLUCURONIDEWW64GZ6LQYACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
CAPSAICINS07O44R1ZMACTIB
METHYL SALICYLATELAV5U5022YACTIB

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
Sombra MaxSOMBRA MAXSombra Cosmetics Inc.41623a46-e6e7-907e-e063-6394a90afc4c2025-10-17WarningsExact identifier
ndc (package): 61577-3440-2
ndc (package): 61577-3440-1
ndc (product): 61577-3440
ndc11 (package): 61577344002
ndc11 (package): 61577344001
spl id: 41623a46-e6e8-907e-e063-6394a90afc4c
spl set id: 41623a46-e6e7-907e-e063-6394a90afc4c

Reported adverse events (FAERS/openFDA)#

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