DOULEURIN TOPICAL PAIN RELIEF- methyl salicylate, capsaicin, menthol lotion

Douleurin Topical Pain Relief by

Drug Labeling and Warnings

Douleurin Topical Pain Relief by is a Otc medication manufactured, distributed, or labeled by Ventriq, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENTS:

Methyl Salicylate 25%

Capsaicin 0.025%

Menthol 10%

PURPOSE

Topical Analgesic

USES:

Temporarily relieves inflammation, mild aches and pains of muscle joints.

WARNINGS:

Only for external use.

Do not use:

on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.

Consult your physician:

if pain is persistent or worsens or if using any other topical pain products.

Call poison control if swallowed. If contact with eyes occurs, rinse eyes thoroughly with cold water.

Keep out of reach of children.

Consult physician for children under 12.

DIRECTIONS:

Wash and dry affected area. Shake bottle well before each use and gently rub over area of pain. Use is not recommended more than four times a day. Wash hands immediately aftwards and avoid contact with eyes.

INACTIVE INGREDIENTS:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cannabis Sativus (Hemp) Seed oil, Cetyl Alcohol, Dimethyl Sulfoxide (DMSO), DMDM Hydantoin, Emulsifying Wax NF, Ethoxydiglycol, Ethylhexylglycerin, Glyceryl Stearate, Magnesium Sulfate, Methylsulfonylmethane MSM, PEG-100 Stearate, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Stearic Acid, Stearyl Alcohol, Triethanolamine, Valeriana Officinalis (Valerian) Root Extract, Xanthan Gum.

Package Labeling:

INGREDIENTS AND APPEARANCE

DOULEURIN TOPICAL PAIN RELIEF 
methyl salicylate, capsaicin, menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72360-331
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	25 mg  in 1 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
HEMP (UNII: TD1MUT01Q7)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
DMDM HYDANTOIN (UNII: BYR0546TOW)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)
VALERIAN (UNII: JWF5YAW3QW)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72360-331-00	1 in 1 CARTON	06/01/2018
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2018

Labeler - Ventriq, LLC (081215461)