Your browser does not support JavaScript! DEEP REMEDY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]
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RxNorm Names

DEEP REMEDY (menthol camphor) gel
[SOMBRA COSMETICS INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61577-3610
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL.03 g  in 1 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC).03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF  
CAPSICUM 
CARBOMER HOMOPOLYMER TYPE C 
DECYL GLUCOSIDE  
WATER 
GRAPEFRUIT SEED OIL  
GREEN TEA LEAF 
ORANGE PEEL  
FILIPENDULA ULMARIA FLOWER  
ROSA CENTIFOLIA FLOWER OIL  
SODIUM HYDROXYMETHYLGLYCINATE  
GLYCERIN 
WITCH HAZEL  
YUCCA SCHIDIGERA ROOT  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-3610-55 g in 1 POUCH
2NDC:61577-3610-258.7 g in 1 JAR
3NDC:61577-3610-4113.4 g in 1 JAR
4NDC:61577-3610-8226.8 g in 1 JAR
5NDC:61577-3610-114.2 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2013
Labeler - SOMBRA COSMETICS INC. (097464309)
Registrant - SOMBRA COSMETICS INC. (097464309)
Establishment
NameAddressID/FEIBusiness Operations
SOMBRA COSMETICS INC.097464309manufacture(61577-3610), label(61577-3610)

Revised: 1/2013
 
SOMBRA COSMETICS INC.

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