Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameMENTHOL
Labeler / manufacturerGlobal America Group LLC
RouteTOPICAL
Drug classDrug class not supplied in source label
Product NDC87843-311
Label effective date2026-09-02
Official product label reference
FREEZE EASE Roll-On — Global America Group LLC
This page contains 11 source sections for MENTHOL, topical route. Label set 1869cc0d-a056-45de-aede-23b09b61ed12, version 1.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Purpose
Purpose Topical analgesic
Dosage and administration — label text
Directions 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
Warnings
Warnings For external use only. Flammable: Keep away from excessive heat or open flame. When using this product 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 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.
Unclassified section
Drug Facts
Manufactured for: GAG GLOBAL AMERICA GROUP Global America Group LLC Brooklyn, NY 11201
Active ingredient
Active ingredient Menthol 4%
While using this medicine
When using this product 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
When to stop use and seek help
Stop use and ask a doctor if 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.
Child safetyStorage and handling
Other information 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.
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.