NUMM WARM SIZZLE- menthol camphor gel 
SOMBRA COSMETICS INC.

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Numm Warm Sizzle Tpoical Pain Relief Gel

Active Ingredients

Camphor 3%, Menthol 3%

Purpose

Purpose External Analgesic

Keep out of reach of childern

Keep out of reach of childern

Uses

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

Warnings

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

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

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

1-800-225-3963

image description

NUMM WARM SIZZLE 
menthol camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-4400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC).03 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
CAPSICUM (UNII: 00UK7646FG)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
WITCH HAZEL (UNII: 101I4J0U34)  
ORANGE OIL (UNII: AKN3KSD11B)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-4400-1226.8 g in 1 JAR; Type 0: Not a Combination Product10/11/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM10/11/2023
Labeler - SOMBRA COSMETICS INC. (097464309)
Establishment
NameAddressID/FEIBusiness Operations
SOMBRA COSMETICS097464309manufacture(61577-4400) , label(61577-4400)

Revised: 10/2023
Document Id: ccf59c68-2f75-4da5-8ad0-d79e928d87f4
Set id: 43457a2b-1a4d-45fa-9cb7-7fb3b80fdd4b
Version: 2
Effective Time: 20231011
 
SOMBRA COSMETICS INC.