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

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Douleurin Topical Pain Relief Lotion

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:

Label2

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72360-331-00	1 in 1 CARTON	06/01/2018	10/30/2020
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	06/01/2018	10/30/2020

Labeler - Ventriq, LLC (081215461)

Revised: 10/2023

Document Id: 0722844b-27d3-4df4-e063-6394a90ae96e

Set id: 4afc4ea9-0f44-44be-9efc-5d7555448973

Version: 4

Effective Time: 20231007

Ventriq, LLC