MOUNTAIN ICE PAIN RELIEF- menthol gel

Mountain Ice by

Drug Labeling and Warnings

Mountain Ice by is a Otc medication manufactured, distributed, or labeled by Mountainside Medical Equipment, Inc., Fragrance Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients:

Menthol 5%

Purpose

External Analgesic

Uses

Temporary relief of minor aches and pains of muscles and joints associated with osteoarthritis, rheumatoid arthritis, muscle strains, and sprains

Warnings

For external use only.

Flammable; keep away from excessive heat or open flame. Avoid contact with eyes or mucous membranes.

When using this product:

• Do not apply to wounds, damaged skin, or irritated skin.
• Do not apply with other creams, ointments, sprays or liniments.
• Stop use and ask a doctor if: Conditions worsen, skin irritation develops, or condition does not improve after 7 days.

Keep out the reach of children:

If accidentally swallowed seek medical attention immediately or contact Poison Control Center right away.

Directions:

Adults and Children 2 years of age or older: Rub on the affected area evenly no more than 4 time. Children under 2 years of age: Consult with your doctor.

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Carbomer, Cinnamomum Camphora (Camphor) Bark Oil, Curcuma longa (Turmeric) Root Oil, Dimethyl Sulfone, Ethylhexylglycerin, Glucosamine HCl, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Limonene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Polysorbate 20, Propanediol, Sodium Chondroitin Sulfate, Sodium Hyaluronate, Tocopheryl Acetate, Triethanolamine, Water (Aqua).

Package/Label Principal Display Panel – Tube Label

Arthritis Pain Relieving Gel

MOUNTAIN ICE

Tumeric, Glucosamine, Chondroitin, Methylsulfonylmethane (MSM), Camphor, Menthol 5%, Arnica Montana, Aloe Vera, Tea Tree Oil, Hyaluronic acid, Vitamin E, Ilex Paraguariensis Leaf Extract.

4 fl oz (118 mL)

Label

Package/Label Principal Display Panel – Bottle Label

Arthritis Pain Relieving Gel

MOUNTAIN ICE

Tumeric, Glucosamine, Chondroitin, Methylsulfonylmethane (MSM), Camphor, Menthol 5%, Arnica Montana, Aloe Vera, Tea Tree Oil, Hyaluronic acid, Vitamin E, Ilex Paraguariensis Leaf Extract.

1 fl oz (30 mL)

Label

INGREDIENTS AND APPEARANCE

MOUNTAIN ICE  PAIN RELIEF
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72793-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CAMPHOR OIL (UNII: 75IZZ8Y727)
TURMERIC OIL (UNII: 6KGS8SP16U)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
TEA TREE OIL (UNII: VIF565UC2G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPANEDIOL (UNII: 5965N8W85T)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72793-100-01	118 g in 1 TUBE; Type 0: Not a Combination Product	05/28/2019
2	NDC: 72793-100-02	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/28/2019

Labeler - Mountainside Medical Equipment, Inc. (119735871)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing, Inc.		793406000	MANUFACTURE(72793-100)