SOMBRA COOL THERAPY- menthol 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 Cool Therapy Natural Pain Relieving Gel

Active Ingredients

Menthol USP 6%

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 carbomer, citrus grandis (grapefruit) seed extract, citrus limon (lemon) peel oil, 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

label

SOMBRA COOL THERAPY 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-3221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.06 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)  
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 ROOT (UNII: E2H9ET15AT)  
LEMON OIL (UNII: I9GRO824LL)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-3221-13628.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/17/2022
2NDC:61577-3221-2907.2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/17/2022
3NDC:61577-3221-3226.8 g in 1 JAR; Type 0: Not a Combination Product05/17/2022
4NDC:61577-3221-4113.4 g in 1 JAR; Type 0: Not a Combination Product05/17/2022
5NDC:61577-3221-6113.4 g in 1 TUBE; Type 0: Not a Combination Product05/17/2022
6NDC:61577-3221-756.7 g in 1 JAR; Type 0: Not a Combination Product05/17/2022
7NDC:61577-3221-95 g in 1 POUCH; Type 0: Not a Combination Product05/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/17/2022
Labeler - SOMBRA COSMETICS INC. (097464309)
Establishment
NameAddressID/FEIBusiness Operations
SOMBRA COSMETICS INC.097464309manufacture(61577-3221) , label(61577-3221)

Revised: 5/2022
Document Id: 5fe37a57-1a13-4f93-af5a-9c1899c2c066
Set id: 87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3
Version: 7
Effective Time: 20220517
 
SOMBRA COSMETICS INC.