FDA.reportPublic FDA data

Deep Core Pain Relieving Gel Warm Therapy

Manufacturer
SOMBRA COSMETICS INC.
Effective date
2024-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:18

Label at a glance#

ProductDeep Core Pain Relieving Gel Warm Therapy
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

Adults 18 years and above : Apply thin layer to the affected area not more than 3-4 times daily. Massage until cream absorbs into skin. Wash hands with water and soap after application. Adults and children 2 - 18 years of age consult a doctor before use. Children aged under 2, do not use.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 3%, Camphor 3%, Capsaicin 0.025%

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

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

Warnings

WARNINGS SECTION

For external use only. Do not use on wounds, damaged, broken, or irritated skin. Do not bandage tightly or apply heating pads or medicated patch to the area of use. If pregnant or breast feedong, ask a healthcare professional before use. Keep out of reach of children and pets.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults 18 years and above: Apply thin layer to the affected area not more than 3-4 times daily. Massage until cream absorbs into skin. Wash hands with water and soap after application. Adults and children 2 - 18 years of age consult a doctor before use. Children aged under 2, do not use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Arnica Montana Extract, Camellia Sinensis Leaf Extract, Carbomer, Citrus Aurantium Dulcis (orange) Peel Oil, Citrus Grandis (Grapefruit) Fruit Extract, Decyl Glucoside, Dimethyl Isosorbide, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate 20, Purified Water, Pyridoxine Hydrochloride (Vitamin B6), Sodium Carbonate, Tocopheryl Acetate, Vernonia Amygdalina (Bitter Leaf) Extract, Witch Hazel Extract.

Questions or Comments

OTC - QUESTIONS SECTION

505-492-4611

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Deep Core Warm TherapyDeep Core Warm Therapy

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-2800-1Deep Core Pain Relieving Gel Warm Therapy85.05 g in 1 BOTTLEGEL85.051

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-2800DEEP CORE PAIN RELIEVING GEL WARM THERAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]11 package rows20240302_d32d1fa7-b7ee-44f0-bfde-9c1a37bff062.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-280061577-2800-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
ALOE AFRICANA LEAFS937Y6JPCZIACT
GLYCERINPDC6A3C0OXIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
ARNICA MONTANA FLOWER WATERU7L2JP51PRIACT
CAPSAICINS07O44R1ZMIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
GRAPEFRUIT SEED OIL598D944HOLIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
VERNONIA APPENDICULATA LEAF4SO50QHC3BIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
ORANGE PEELTI9T76XD44IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
POLYSORBATE 207T1F30V5YHIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM CARBONATE45P3261C7TIACT

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
ab9a4338-21e5-402c-9910-e1f1b4e7ad52d32d1fa7-b7ee-44f0-bfde-9c1a37bff0622024-03-01WarningsExact identifier
spl id: ab9a4338-21e5-402c-9910-e1f1b4e7ad52
spl set id: d32d1fa7-b7ee-44f0-bfde-9c1a37bff062

Reported adverse events (FAERS/openFDA)#

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