DOULEURIN ICE PAIN RELIEF- methyl salicylate, menthol lotion

DOULEURIN ICE PAIN RELIEF by

Drug Labeling and Warnings

DOULEURIN ICE 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 10%

Menthol 4%

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 mucosus 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: (Store in a cool dry place)

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, C12-15 Alkyl Benzoate, Cannabis Sativus (Full Spectrum Hemp) Seed Oil, Capsaicin, Chamomilla Recutita (Chamomile) Extract, Cetearyl Olivate, Cetyl Alcohol, Cetyl Myristoleate, Chondroitin Sulfate, Gluconolactone, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) oil, Ilex Paraguariensis (Yerba Mate') Extract, Isopropyl Myristate, Methylsulfonylmethane (MSM), Magnesium Sulfate, Pantothenic Acid (Vitamin B5), Pyridoxine (Vitamin B6), Salix Nigra (Willow) Bark Extract, Sodium Benzoate, Sorbitan Olivate, Squalane, Tetrasodium EDTA

Package Labeling:

INGREDIENTS AND APPEARANCE

DOULEURIN ICE PAIN RELIEF 
methyl salicylate, menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72360-341
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 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)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPSAICIN (UNII: S07O44R1ZM)
CHAMOMILE (UNII: FGL3685T2X)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LICORICE (UNII: 61ZBX54883)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PANTOTHENIC ACID (UNII: 19F5HK2737)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SQUALANE (UNII: GW89575KF9)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72360-341-00	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/01/2020

Labeler - Ventriq, LLC (081215461)