TONYS WARM THERAPY- menthol camphor gel 
Sombra Cosmetics

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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Dr Tonys Warm Therapy

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 arches and pains of muscles and joints associated with: arthritis, simple backaches.

warnings

​For external use only. ​Do not use on wounds or damage skin. When using this product :​ avoid bandaging tightly, aviod contact with eyes, ​keep out of mreach of childern​.

​Stop use and ask doctor if :​ condition worsens, symptoms persist for more than 7 days, clear up and within a few days.

Directions

adults and childern 2 years of age and older:​ apply to affected area not more than 3 to 4 times daily, rub in thoroughtly until gel is absorbed, Childern 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 aurantium dulcis (orange) 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, capsicum annuum fruit extract

Questions or Comments

1-800-225-3963

Dr Tony Warm Therapy

TONYS WARM THERAPY 
menthol camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-1400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.03 g  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
WATER (UNII: 059QF0KO0R)  
CAPSAICIN (UNII: S07O44R1ZM)  
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
GLYCERIN (UNII: PDC6A3C0OX)  
WITCH HAZEL (UNII: 101I4J0U34)  
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
ORANGE PEEL (UNII: TI9T76XD44)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-1400-385 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/13/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/13/2021
Labeler - Sombra Cosmetics (097464309)
Establishment
NameAddressID/FEIBusiness Operations
Sombra Cosmetics097464309manufacture(61577-1400)

Revised: 9/2021
Document Id: 458cc057-fb93-4aa4-adc1-7c016c9b38d5
Set id: c3da38ad-199e-436d-9374-afd1da36c473
Version: 1
Effective Time: 20210913
 
Sombra Cosmetics