SORE NO MORE WARM THERAPY- menthol and 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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Sore No More Warm  Therapy Natural Pain Relieving Gel

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, camellia sinensis (green tea) leaf extract, caprylyl glycol, capsicum annuum fruit extract, carbomer, citrus aurantium 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 carbonate, yucca schidigera root extract.

Questions or Comments

1-800-225-3963

Label

SORE NO MORE WARM THERAPY 
menthol and camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-3234
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)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
GLYCERIN (UNII: PDC6A3C0OX)  
WITCH HAZEL (UNII: 101I4J0U34)  
YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)  
ORANGE PEEL (UNII: TI9T76XD44)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-3234-4113.4 g in 1 JAR; Type 0: Not a Combination Product05/16/2022
2NDC:61577-3234-828.3 g in 1 PACKAGE; Type 0: Not a Combination Product05/16/2022
3NDC:61577-3234-2907.2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/16/2022
4NDC:61577-3234-3226.8 g in 1 JAR; Type 0: Not a Combination Product05/16/2022
5NDC:61577-3234-585 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2022
6NDC:61577-3234-6113.4 g in 1 TUBE; Type 0: Not a Combination Product05/16/2022
7NDC:61577-3234-756.7 g in 1 JAR; Type 0: Not a Combination Product05/16/2022
8NDC:61577-3234-95 g in 1 POUCH; Type 0: Not a Combination Product05/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/16/2022
Labeler - SOMBRA COSMETICS INC. (097464309)
Registrant - SOMBRA COSMETICS (097464309)
Establishment
NameAddressID/FEIBusiness Operations
SOMBRA COSMETICS INC.097464309manufacture(61577-3234) , label(61577-3234)

Revised: 5/2022
Document Id: 969d96cc-62f1-41ba-90f4-823ca0be85a7
Set id: cd86b56e-9b4c-4aca-9740-c8793cb12055
Version: 8
Effective Time: 20220516
 
SOMBRA COSMETICS INC.