OTC Medication Information: Mountain Ice Pain Relief

MOUNTAIN ICE PAIN RELIEF- menthol, unspecified form gel
Mountainside Medical Equipment, Inc.

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), Blue 1 (CI 42090).

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)

image-01
(click image for full-size original)

Label

MOUNTAIN ICE PAIN RELIEF
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72793-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
ARNICA MONTANA FLOWER
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
CAMPHOR OIL
TURMERIC OIL
DIMETHYL SULFONE
ETHYLHEXYLGLYCERIN
GLUCOSAMINE HYDROCHLORIDE
GLYCERIN
ILEX PARAGUARIENSIS LEAF
ISOPROPYL ALCOHOL
LIMONENE, (+)-
TEA TREE OIL
PHENOXYETHANOL
POLYSORBATE 20
PROPANEDIOL
HYALURONATE SODIUM
.ALPHA.-TOCOPHEROL ACETATE
TROLAMINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72793-100-01 118 mL in 1 TUBE None
2 NDC:72793-100-02 30 mL in 1 BOTTLE, PUMP None
3 NDC:72793-100-03 946 mL in 1 BOTTLE, PUMP None
4 NDC:72793-100-04 6 mL in 1 PACKET None
5 NDC:72793-100-05 99 mL in 1 BOTTLE, WITH APPLICATOR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 05/28/2019
Labeler — Mountainside Medical Equipment, Inc. (119735871)
Establishment
Name Address ID/FEI Operations
Fragrance Manufacturing, Inc. 793406000 MANUFACTURE (72793-100)

Revised: 12/2023 Mountainside Medical Equipment, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.