THERAID by SOMBRA COSMETICS INC. THERAID- menthol gel

THERAID by

Drug Labeling and Warnings

THERAID by is a Otc medication manufactured, distributed, or labeled by SOMBRA COSMETICS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

theraid.jpg

INGREDIENTS AND APPEARANCE

THERAID  
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-3710
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-3710-1	113.4 g in 1 JAR
2	NDC: 61577-3710-2	36.9 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/20/2013

Labeler - SOMBRA COSMETICS INC. (097464309)

Registrant - SOMBRA COSMETICS INC. (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
SOMBRA COSMETICS INC.		097464309	manufacture(61577-3710) , label(61577-3710)