FREEZE EASE Roll-On

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from excessive heat or open flame.

When using this product

OTC - WHEN USING SECTION

• use only as directed
• avoid contact with the theeyes or on mucous membranes
• do not apply to wounds or damaged skin
• do not apply to irritated skin or if excessive irritation develops
• do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if

OTC - STOP USE SECTION

• you experience pain, swelling or blistering of the skin
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• arthritis pain persists for more than 10 days, or rednessis present. allergic reaction occurs
• If pregnant or breast-feeding, ask a health professional before use.
• Keep out of reach of children. If swallowed, get medical help orcontact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 5 years of age and older: apply externally to the affected area up to 3 to 4 times daily
• children under 5 years of age: consult a physician
• wash hands after use with cool water

Other information

STORAGE AND HANDLING SECTION

• may be applied under occlusive dressing
• store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

GLYCERIN MONOSTEARATE ACETATE, ARNICA MONTANA FLOWER EXTRACT, GREEN TEA LEAF EXTRACT, LEMON OIL, ISOPROPYL ALCOHOL, CARBOMER, HOMOPOLYMER, BEESWAX, CASTOR OIL, ALPHA-TOCOPHEROL ACETATE, TROLAMINE, WATER.

SPL UNCLASSIFIED SECTION

Manufactured for:

GAG
GLOBAL AMERICA
GROUP

Global America Group LLC
Brooklyn, NY 11201

Questions or comments?

OTC - QUESTIONS SECTION

646-457-4800

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:87843-311-50

FREEZE
EASE

MENTHOL 4% ROLL-ON

COOLING PAIN RELIEF GEL

50 mL

Product Linked Resources#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

• FREEZE EASE Roll-On
• MENTHOL
• GLYCERYL MONOSTEARATE
• ARNICA MONTANA WHOLE
• GREEN TEA LEAF
• LEMON OIL, COLD PRESSED
• ISOPROPYL ALCOHOL
• CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
• BOSWELLIA SACRA WHOLE
• .ALPHA.-TOCOPHEROL ACETATE
• TROLAMINE
• WATER
• MENTHOL, UNSPECIFIED FORM

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.