SE SPORT ENDURANCE PAIN FREEZE RECOVERY- menthol gel

SE Sport Endurance Pain Freeze Recovery by

Drug Labeling and Warnings

SE Sport Endurance Pain Freeze Recovery by is a Otc medication manufactured, distributed, or labeled by Sport Endurance, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient:

Menthol - USP 14%

Purpose:

Anesthetic/Analgesic

Other ingredients:

Aqua (Deionized Water), Arnica Montana Flower (Arnica) Extract, Boswella serrata Extract, Carbomer, Chondroitin Sulfate, Eucalyptus Globulus Oil, Glucosamine sulfate, Glycrrhiza Glabra (Licorice) Extract. Ilex Paraguariensis leaf (Yerba Mate) Extract, Mentha Piperita (Peppermint) Oil, Methylisothiazolinone (MSM), Polysorbate-20, SD-Alcohol 40B, Triethanolarmine

Directions:

Apply directly to affected area. Do use more than four times per day.

Uses:

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains, and/or sprains.

Warnings:

• For external use only
• Avoid contact with eyes
• Do not apply to open wounds of damaged skin
• If symptoms persist for more than seven days, discontinue use and consult physician

Keep out of reach of children

if swallowed, consult physician

• Do not bandage tightly

Package Labeling:

INGREDIENTS AND APPEARANCE

SE SPORT ENDURANCE PAIN FREEZE RECOVERY 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70909-757
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	140 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70909-757-01	88.7 mL in 1 CONTAINER; Type 0: Not a Combination Product	08/13/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/13/2016

Labeler - Sport Endurance, Inc (099632379)