Pain Relief Gel-Roll On LIDOCAINE AND MENTHOL BULLET POINT LLC FDA Approved Use Temporary relief of pain Do not use • On large areas of the body or on cut, irritated, or swollen skin not apply to wounds or damaged 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 label • Do not allow contact with eyes and mucous membranes • Do not bandage or apply local heat (such as heating patches) or a medicated patch to the area of use • Do not use at the same time as other topical analgesics Stop use if • Condition worsens • Redness is present • Irritation develops • Symptoms persist for more than 7 days or clear up and occur within a few days
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Substance Lidocaine
Route
TOPICAL
Applications
M017

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic) Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)
Inactive Ingredients
Inactive Ingredients Aloe Vera Extract Carbomer Isopropyl myristate Lavender Oil Phenoxyethanol Polysorbate 80 Propylene Glycol Tartaric acid Vitamin E Water
Strengths
4.0 % 1.0 %
Treats Conditions
Use Temporary Relief Of Pain Do Not Use On Large Areas Of The Body Or On Cut Irritated Or Swollen Skin Not Apply To Wounds Or Damaged 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 Label Do Not Allow Contact With Eyes And Mucous Membranes Do Not Bandage Or Apply Local Heat Such As Heating Patches Or A Medicated Patch To The Area Of Use Do Not Use At The Same Time As Other Topical Analgesics Stop Use If Condition Worsens Redness Is Present Irritation Develops Symptoms Persist For More Than 7 Days Or Clear Up And Occur Within A Few Days

Identifiers & Packaging

Container Type UNKNOWN
UPC
5060643133300
UNII
98PI200987 L7T10EIP3A
Packaging

Principal Display Panel

Package Descriptions
  • Principal Display Panel

Overview

Use Temporary relief of pain Do not use • On large areas of the body or on cut, irritated, or swollen skin not apply to wounds or damaged 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 label • Do not allow contact with eyes and mucous membranes • Do not bandage or apply local heat (such as heating patches) or a medicated patch to the area of use • Do not use at the same time as other topical analgesics Stop use if • Condition worsens • Redness is present • Irritation develops • Symptoms persist for more than 7 days or clear up and occur within a few days

Indications & Usage

Use Temporary relief of pain Do not use • On large areas of the body or on cut, irritated, or swollen skin not apply to wounds or damaged 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 label • Do not allow contact with eyes and mucous membranes • Do not bandage or apply local heat (such as heating patches) or a medicated patch to the area of use • Do not use at the same time as other topical analgesics Stop use if • Condition worsens • Redness is present • Irritation develops • Symptoms persist for more than 7 days or clear up and occur within a few days

Dosage & Administration

Directions Adults and children 12 years of age and over: Apply a thin layer to the affected area for 6 to 8 hours Not to exceed 3 applications in a 24 hour period Children under 12 years old: Consult a doctor

Warnings & Precautions
Warnings For external use only
Purpose

Purpose (Lidocaine) Topical Anesthetic (Menthol) Topical Analgesic

Keep Out of Reach of Children

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


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