Drugplain

Pain Relieving Roll-On 7 g/100mL

menthol, unspecified form · GEL · Safetec of America, Inc.

1 Recall on Record
Plain English

Pain Relieving Roll-On is a gel containing menthol, unspecified form at 7 g/100mL, taken topical. Manufactured by Safetec of America, Inc..

Key Facts

Brand Name
Pain Relieving Roll-On
Generic Name
menthol, unspecified form
NDC Code (Product)
61010-1550
Manufacturer
Safetec of America, Inc.
Strength
7 g/100mL
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
10/07/2019

Recall History

1 Recall on Record
Class II06/21/2019

Pharma-Natural Inc.

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective475 reports
drug hypersensitivity468 reports
pain197 reports
off label use145 reports
dyspnoea140 reports
fatigue139 reports
dizziness129 reports
headache115 reports
nausea107 reports
pruritus105 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily relieves minor pain

Dosage & Administration

Directions Directions adults and children over 12 years:■apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period. children 12 years or younger: ■ask a doctor

Warnings

Warning For External use only Do not use■on large areas of the body or on cut, irritated or swollen skin ■on puncture wounds ■ for more than one week without consulting a doctor When using this product ■use only as directed. Read and follow all directions and warnings on this carton ■ do not allow contact with the eyes and mucous membranes ■do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use ■do not use at the same time as other topical analgesics Stop use and ask a doctor if ■condition worsens ■ redness is present ■irritation develops ■symptoms persist for more than 7 days or clear up and occur again within a few days Flammable Keep away from fire or flame Store at room temperature If pregnant or breast feeding, ask a health professional before use Keep out if reach of children and pets If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away

Frequently Asked Questions

What is Pain Relieving Roll-On used for?

Pain Relieving Roll-On contains menthol, unspecified form. It is a gel taken topical. Consult your doctor for specific uses.

Is Pain Relieving Roll-On a controlled substance?

Pain Relieving Roll-On is not classified as a controlled substance by the DEA.

What is the generic name for Pain Relieving Roll-On?

The generic name for Pain Relieving Roll-On is menthol, unspecified form. There are 11 other brand versions of menthol, unspecified form.

What is the NDC code for Pain Relieving Roll-On 7 g/100mL?

The NDC (National Drug Code) for Pain Relieving Roll-On 7 g/100mL is 61010-1550, listed by Safetec of America, Inc..