Stopain Cold Professional Strength Pain Relieving Gel

Stopain Cold Professional Strength Pain Relieving by

Drug Labeling and Warnings

Stopain Cold Professional 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]

STOPAIN COLD PROFESSIONAL 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.

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Stopain Cold Professional Strength Pain Relieving Gel

Drug Facts

Active Ingredient

Menthol 8.0%

Purpose

Topical Analgesic

Uses: For the temporary relief of minor aches and pains of muscle 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 symptoms persist for more than 7 days or clear up and occur again within a few days.
  • redness is present
  • excessive irritation of the 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 as 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, acrylate copolymer, Boswellia serrata extract, carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerin, peppermint oil, SD alcohol 39-C, triethanolamine, water

Manufactured for: Troy Healthcare, LLC 130 Lions Drive, Hazleton, PA 18202

800-201-PAIN (7246)

www.stopain.com

NOTHING LASTS LONGER

PROFESSIONAL STRENGTH

STOPAIN COLD

PAIN RELIVING GEL

Immediate, Penetrating Pain Relief From:

Arthritis

Muscle Aches

Back Pain

Stopain. Exactly what it does.

Sweat resistant

Non-greasy

Easy to use

Pharmacist recommended

Our pharmacist recommended formulas:

Work on contact

Provide long-lasting pain relief

Does not contain aspirin, acetaminophen, dyes, fragrances or parabens

For more information, visit www.stopain.com today.

made in USA

To report a serious adverse event, contact (800) 201 PAIN (7246)

Stopain Cold Professional Strength Pain Relieving Gel

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STOPAIN COLD PROFESSIONAL STRENGTH PAIN RELIEVING 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63936-8750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL80 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ALCOHOL (UNII: 3K9958V90M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63936-8750-13510 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/03/201412/21/2015
2NDC: 63936-8750-2440 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/03/201412/21/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/03/201412/21/2015
Labeler - TROY MANUFACTURING, INC (160075248)
Registrant - TROY MANUFACTURING, INC (160075248)
Establishment
NameAddressID/FEIBusiness Operations
TROY MANUFACTURING, INC160075248manufacture(63936-8750)

Revised: 12/2019
Document Id: 99820b99-64a3-998b-e053-2995a90a7fb5
Set id: 38e07171-9ec9-453c-ac01-ed8bf837a223
Version: 2
Effective Time: 20191212
 
TROY MANUFACTURING, INC