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

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Mountain Ice Pain Relief Gel

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

Label

MOUNTAIN ICE  PAIN RELIEF
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72793-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72793-100-01118 mL in 1 TUBE; Type 0: Not a Combination Product05/28/2019
2NDC:72793-100-0230 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/28/201906/14/2022
3NDC:72793-100-03946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/06/2019
4NDC:72793-100-046 mL in 1 PACKET; Type 0: Not a Combination Product12/06/2019
5NDC:72793-100-0599 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/28/2019
Labeler - Mountainside Medical Equipment, Inc. (119735871)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing, Inc.793406000MANUFACTURE(72793-100)

Revised: 12/2023
Document Id: 23bdbae2-2f37-4315-a8f0-58d6d8a08193
Set id: c79fdd91-16f4-4ae0-bee4-d37c05ed2074
Version: 4
Effective Time: 20231222
 
Mountainside Medical Equipment, Inc.