TONYS WARM THERAPY- menthol camphor gel

Tonys Warm Therapy by

Drug Labeling and Warnings

Tonys Warm Therapy by is a Otc medication manufactured, distributed, or labeled by Sombra Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TONYS WARM THERAPY 
menthol camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-1400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.03 g  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.03 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-1400-3	85 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	09/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/13/2021

Labeler - Sombra Cosmetics (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
Sombra Cosmetics		097464309	manufacture(61577-1400)