STOPAIN EXTRA STRENGTH PAIN RELIEVING- menthol gel 
Troy Manufacturing, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Stopain Extra Strength Pain Relieving Gel

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

BoxL

TubeL

STOPAIN EXTRA STRENGTH PAIN RELIEVING 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63936-0875
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.08 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63936-0875-15 g in 1 PACKET; Type 0: Not a Combination Product02/12/201512/21/2015
2NDC:63936-0875-21 in 1 BOX02/12/201510/01/2020
2110 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/12/201510/01/2020
Labeler - Troy Manufacturing, Inc. (160075248)
Establishment
NameAddressID/FEIBusiness Operations
Troy Manufacturing, Inc.160075248manufacture(63936-0875)

Revised: 10/2020
 
Troy Manufacturing, Inc.