Drugplain

EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON 80 mg/mL

MENTHOL · LIQUID · TROY MANUFACTURING, INC

No Recall History
Plain English

EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON is a prescription liquid containing menthol at 80 mg/mL, taken topical. Manufactured by TROY MANUFACTURING, INC.

Key Facts

Brand Name
EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON
Generic Name
MENTHOL
NDC Code (Product)
63936-8523
Manufacturer
TROY MANUFACTURING, INC
Strength
80 mg/mL
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
HUMAN OTC DRUG
Application #
M017
Marketing Start
10/13/2010

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use92 reports
drug ineffective82 reports
dyspnoea82 reports
fatigue81 reports
pain75 reports
pruritus72 reports
cough65 reports
dizziness65 reports
headache63 reports
drug hypersensitivity58 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains

Dosage & Administration

Directions Adults and children 2 years of age and older: • apply directly onto affected area, not more than 3 to 4 times daily •wash hands after use Children under 2 years of age: do not use, consult a doctor

Warnings

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 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.

Frequently Asked Questions

What is EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON used for?

EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON contains MENTHOL. It is a liquid taken topical. Consult your doctor for specific uses.

Is EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON a controlled substance?

EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON is not classified as a controlled substance by the DEA.

What is the generic name for EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON?

The generic name for EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON is MENTHOL. There are 12 other brand versions of MENTHOL.

What is the NDC code for EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON 80 mg/mL?

The NDC (National Drug Code) for EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON 80 mg/mL is 63936-8523, listed by TROY MANUFACTURING, INC.