STOPAIN EXTRA STRENGTH PAIN RELIEVING- menthol gel

Stopain Extra Strength Pain Relieving by

Drug Labeling and Warnings

Stopain Extra Strength Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Troy Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Menthol 8.0%

Purpose

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only.  Avoid contact with eyes.

​Flammable:  Keep away from fire or flame.

When using this product

• use only as directed
• do not bandage tightly or use a heating pad
• do not apply to wounds or damaged skin.

Stop use and ask a doctor if

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present
• excessive irritation of skin develops

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years: apply directly onto affected area without the need to bandage.  repeat if necessary, but do not apply more than 4 times daily.  ​Children 12 years or younger: ​ask a doctor

Other Information

• Store at room temperature.

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, acrylates copolymer, boswellia serrata extract, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerin, peppermint oil, SD alcohol 39C, silica, triethanolamine, water.

Product Labels

INGREDIENTS AND APPEARANCE

STOPAIN EXTRA STRENGTH PAIN RELIEVING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63936-0875
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.08 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63936-0875-1	5 g in 1 PACKET; Type 0: Not a Combination Product	02/12/2015	12/21/2015
2	NDC: 63936-0875-2	1 in 1 BOX	02/12/2015
2		110 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/12/2015

Labeler - Troy Manufacturing, Inc. (160075248)

Establishment
Name	Address	ID/FEI	Business Operations
Troy Manufacturing, Inc.		160075248	manufacture(63936-0875)