EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING- menthol spray

EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING by

Drug Labeling and Warnings

EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING by is a Otc medication manufactured, distributed, or labeled by TROY MANUFACTURING, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Warnings

For eternal use only. Avoid contact with eyes.

Flammable: Keep away from fire or flame

WHEN USING

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

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, aska health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children over 12 years: spray directly onto affected area without the need to rub, massage or 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

citric acid, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, peppermint oil, SD alcohol 30-C, water

SPL UNCLASSIFIED SECTION

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

800-201-PAIN (7246)

www.stopain.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63936-8504
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
PEPPERMINT OIL (UNII: AV092KU4JH)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63936-8504-1	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/13/2010	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/13/2010	12/31/2020

Labeler - TROY MANUFACTURING, INC (160075248)

Registrant - TROY MANUFACTURING, INC (160075248)

Establishment
Name	Address	ID/FEI	Business Operations
TROY MANUFACTURING, INC		160075248	manufacture(63936-8504)