SOMBRA WARM THERAPY- menthol camphor gel 
SOMBRA COSMETICS INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sombra Warm Therapy Natural Pain Relieving Gel Canada

Active Ingredients

Menthol USP 3%, Camphor USP 3%

Purpose

Purpose
External Analgesic

Keep out of reach of children

Keep out of reach of children

Uses

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

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, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus aurantium dulcis (orange) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl glycol, capsicum annuum fruit extract

Questions or Comments

1-800-225-3963

image description

SOMBRA WARM THERAPY 
menthol camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-4020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.03 g  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
WATER (UNII: 059QF0KO0R)  
CAPSAICIN (UNII: S07O44R1ZM)  
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
GLYCERIN (UNII: PDC6A3C0OX)  
WITCH HAZEL (UNII: 101I4J0U34)  
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
ORANGE PEEL (UNII: TI9T76XD44)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-4020-13628.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/10/2023
2NDC:61577-4020-2907.2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/10/2023
3NDC:61577-4020-3226.8 g in 1 JAR; Type 0: Not a Combination Product03/10/2023
4NDC:61577-4020-4113.4 g in 1 JAR; Type 0: Not a Combination Product03/10/2023
5NDC:61577-4020-585 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/10/2023
Labeler - SOMBRA COSMETICS INC. (097464309)
Establishment
NameAddressID/FEIBusiness Operations
SOMBRA COSMETICS INC.097464309manufacture(61577-4020) , label(61577-4020)

Revised: 3/2023
Document Id: 61ae97fa-54a7-4a90-a7a0-287b8f34fe5e
Set id: b0d64c55-3d11-4659-9195-136b05ffe3d7
Version: 9
Effective Time: 20230310
 
SOMBRA COSMETICS INC.