DEEP REMEDY  - menthol and camphor (synthetic) 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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Deep Remedy 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:  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, deinoized water, grapefruit seed extract, green tea extract, orange peel extract, queen of the prairie extract, rose water, sodium  hydroxymethylglycinate, vegetable glycerin, witch hazel, yucca extract

Questions or Comments

1-800-225-3963

label


deep30001.jpg
DEEP REMEDY  
menthol camphor gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61577-3610
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .03 g  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) .03 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)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ORANGE PEEL (UNII: TI9T76XD44)  
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
GLYCERIN (UNII: PDC6A3C0OX)  
WITCH HAZEL (UNII: 101I4J0U34)  
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61577-3610-5 5 g in 1 POUCH
2 NDC:61577-3610-2 58.7 g in 1 JAR
3 NDC:61577-3610-4 113.4 g in 1 JAR
4 NDC:61577-3610-8 226.8 g in 1 JAR
5 NDC:61577-3610-1 14.2 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 01/01/2013
Labeler - SOMBRA COSMETICS INC. (097464309)
Registrant - SOMBRA COSMETICS INC. (097464309)
Establishment
Name Address ID/FEI Business Operations
SOMBRA COSMETICS INC. 097464309 manufacture(61577-3610) , label(61577-3610)

Revised: 1/2013
Document Id: 1fb514f2-a819-4350-94c5-d1606b4bbe5f
Set id: dcfd0511-39d9-4221-b111-947f0785e043
Version: 2
Effective Time: 20130117
 
SOMBRA COSMETICS INC.