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SOMBRA COOL THERAPY

Dosage form: gel
Ingredients: MENTHOL .06g in 1g
Labeler: SOMBRA COSMETICS INC.
NDC Code: 61577-3221

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.

Sombra Cool Therapy Natural Pain Relieving Gel

Active Ingredients

Menthol USP 6%

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: 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, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus limon (lemon) 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

Questions or Comments

1-800-225-3963

SOMBRA COOL THERAPY 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-3221
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CARBOMER HOMOPOLYMER TYPE C 
DECYL GLUCOSIDE  
WATER 
GRAPEFRUIT SEED OIL 
GREEN TEA LEAF 
FILIPENDULA ULMARIA FLOWER 
ROSA CENTIFOLIA FLOWER OIL 
SODIUM CARBONATE 
GLYCERIN 
WITCH HAZEL 
YUCCA SCHIDIGERA ROOT 
LEMON OIL 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
Packaging
#Item CodePackage Description
1NDC:61577-3221-13628.7 g in 1 BOTTLE, PUMP
2NDC:61577-3221-2907.2 g in 1 BOTTLE, PUMP
3NDC:61577-3221-3226.8 g in 1 JAR
4NDC:61577-3221-4113.4 g in 1 JAR
5NDC:61577-3221-585 g in 1 BOTTLE, PLASTIC
6NDC:61577-3221-6113.4 g in 1 TUBE
7NDC:61577-3221-756.7 g in 1 JAR
8NDC:61577-3221-95 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/29/2016
Labeler - SOMBRA COSMETICS INC. (097464309)
Establishment
NameAddressID/FEIOperations
SOMBRA COSMETICS INC.097464309manufacture(61577-3221), label(61577-3221)

Revised: 04/2016
 
SOMBRA COSMETICS INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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