FDA.reportPublic FDA data

Numm Warm Sizzle Tpoical Pain Relief Gel

Manufacturer
SOMBRA COSMETICS INC. | SOMBRA COSMETICS
Effective date
2023-10-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:49

Label at a glance#

ProductNUMM WARM SIZZLE
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

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

OTC - ACTIVE INGREDIENT SECTION

Camphor 3%, Menthol 3%

Purpose

OTC - PURPOSE SECTION

Purpose External Analgesic

Keep out of reach of childern

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childern

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

aloe barbadensis leaf juice,camellia sinensis (green tea) leaf extract, caprylyl glycol, capsicum annuum fruit extract, carbomer, citrus aurntium dulcis (orange) peel oil, citrus grandis (grapefruit) seed extract, decyl glucoside, filipendula ulmaria flower (queen of the prairie) extract, glycerin, hamamelis virginiana (witch hazel) leaf extract, phenoxyethanol, purified water, rosa damascena flower water, sodium carbornate, yucca schidigera stem extract,

Question or comments

OTC - QUESTIONS SECTION

1-800-225-3963

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
630714camphor 3 % / menthol 3 % Topical GelPSN2
630714camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical GelSCD2
630714camphor 3 % / menthol 3 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-4400-12025-01-30C16284748780-12cef2736-7599-d83d-e063-dadaa90ab31fNumm Warm Sizzle Tpoical Pain Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-4400-1NUMM WARM SIZZLE226.8 g in 1 JARGEL226.82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-4400NUMM WARM SIZZLE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]21 package rows20231129_43457a2b-1a4d-45fa-9cb7-7fb3b80fdd4b.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-440061577-4400-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
YUCCA SCHIDIGERA ROOTE2H9ET15ATIACT
CAPSICUM00UK7646FGIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
GRAPEFRUIT SEED OIL598D944HOLIACT
WITCH HAZEL101I4J0U34IACT
ORANGE OILAKN3KSD11BIACT
ROSA CENTIFOLIA FLOWER OILH32V31VMWYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM CARBONATE45P3261C7TIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB

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
ccf59c68-2f75-4da5-8ad0-d79e928d87f443457a2b-1a4d-45fa-9cb7-7fb3b80fdd4b2023-10-11WarningsExact identifier
spl id: ccf59c68-2f75-4da5-8ad0-d79e928d87f4
spl set id: 43457a2b-1a4d-45fa-9cb7-7fb3b80fdd4b

Reported adverse events (FAERS/openFDA)#

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