THERAID  - 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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TherAid Natural Pain Relieving Cream

Active Ingredients

Menthol USP 4%

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, arthritis, 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 vera extract, capsaicin, carbomer, decyl polyglucose, deionized water, emu oil, grapefruit seed extract, orange peel extract, sodium  hydroxymethylglycinate, vegetable glycerin, witch hazel, yucca extract

Questions or Comments

1-888-416-4441


label



theraid.jpg

THERAID  
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-3710
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.04 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAPSICUM (UNII: 00UK7646FG)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
WATER (UNII: 059QF0KO0R)  
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
ORANGE PEEL (UNII: TI9T76XD44)  
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
GLYCERIN (UNII: PDC6A3C0OX)  
WITCH HAZEL (UNII: 101I4J0U34)  
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
EMU OIL (UNII: 344821WD61)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-3710-1113.4 g in 1 JAR
2NDC:61577-3710-236.9 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/20/2013
Labeler - SOMBRA COSMETICS INC. (097464309)
Registrant - SOMBRA COSMETICS INC. (097464309)
Establishment
NameAddressID/FEIBusiness Operations
SOMBRA COSMETICS INC.097464309manufacture(61577-3710) , label(61577-3710)

Revised: 2/2013
Document Id: 81b81277-b098-46ec-8201-a8b7bd8eb0a0
Set id: 354d2b08-2873-42ce-95a0-375db6eee491
Version: 1
Effective Time: 20130220
 
SOMBRA COSMETICS INC.