FDA.reportPublic FDA data

FREEZE EASE MAX

Manufacturer
Global America Group LLC
Effective date
2026-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-30 01:01:13

Label at a glance#

ProductFreeze Ease Max Cream
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Dosage and administration

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 Ask a doctor May be applied under occlusive dressing.

Storage and handling

Store at 20 - 25°C (68 - 77°F); excursions permitted to 15 - 30°C (59 - 86°F). See USP Controlled Room Temperature.

Label contents#

Full prescribing information#

​

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10.5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of minor aches and pains of muscles and joints, associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

​For external use only.

Flammable: keep away from excessive heat or open flame

When using this product

OTC - WHEN USING SECTION

  • only use as directed
  • avoid contact with the eyes 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
  • condition worsens
    or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days
  • allergic reaction occurs
  • If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 years of age and olderApply externally to the affected area up to 3 to 4 times daily
Children under 5 yearsAsk a doctor
  • May be applied under occlusive dressing.

Other information

STORAGE AND HANDLING SECTION

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

GLUCOSAMINE SULFATE,
CHONDROITIN SULFATE,
GLYCERIN MONOSTEARATE ACETATE,
TROLAMINE, STEARIC ACID,
CARBOMER HOMOPOLYMER,
LAURETH-7, WATER

SPL UNCLASSIFIED SECTION

Manufactured for:

Global America Group LLC

Brooklyn, NY 11234

Questions or Comments?

646-457-4800

Made in China

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 87843-313-12

FREEZE
EASE
MAX

MENTHOL 10.5% CREAM

PAIN RELIEF CREAM
Menthol 10.5% Topical Analgesic

FAST ACTING
COOLING RELIEF

HELPS EASE ACHES,
SORE MUSCLE &
JOINTS PAIN

ENRICHED WITH
SOOTHING
BOTANICALS

NON-GREASY
MESS-FREE
EASY TO APPLY

120 mL
(4 FL OZ)

SPORTS

WORKOUT

ACTIVE
LIFESTYLE

EVERYDAY
RELIEF

Freeze EASEFreeze EASE

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130387843313123GTIN-13: 0387843313123
EAN-13: 0387843313123
GTIN-12: 387843313123
UPC-A: 387843313123
GTIN storage (14 digits): 00387843313123		freeze-01.jpg

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87843-31387843-313-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
STEARIC ACID4ELV7Z65APIACT
LAURETH-7Z95S6G8201IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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 4 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meriwether Skin Pain ReliefMENTHOL, UNSPECIFIED FORMMeriwether Skin LLCf6e155be-5879-4176-bb0e-e364f2e5cdf92026-07-16WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
Propolis Cooling Relief Cherry Cough DropsMENTHOL, UNSPECIFIED FORMBeekeeper's Naturals USA Inc7087566d-f24a-4508-aa25-7f42d055c43e2026-07-13WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC00bba5d2-b0e0-701c-e063-6294a90a57412026-05-15WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
Biofreeze Overnight ReliefMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC07be6e88-1850-4d6a-946d-f03830b8c4a22026-05-15WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6bef9ccb-7a5a-4c67-b1bc-a92b167312da2026-05-15WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCdb982baf-31ea-4f09-90e3-cd5facb5dfe52026-05-15WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
Biofreeze Professional Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCf62f8ec3-593d-480a-85a0-01fcd7f1790c2026-05-15WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC3f2b1f48-2d78-4985-a046-9f72de5e1a9b2026-05-13WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
Biofreeze Professional ColorlessMENTHOL, UNSPECIFIED FORMReckitt Benckiser4639201c-a67a-475f-8df6-3dc6225803ad2026-05-12WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCbae9946a-4c68-4759-9fb3-0a61a7ad0eb72026-05-12WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
24 7 Relief and Recovery Pain RelievingMENTHOL, UNSPECIFIED FORMTriplicare Inc53ca807b-3ec2-4b5e-aa5a-6dcb756bb4232026-04-30WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
Stopain ClinicalMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.4503208f-2808-4727-8066-c431230bd70b2026-04-16WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
BonicaEaseX 24 Hour Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co., Ltd.17fc0cd1-710d-45e6-9513-d7100e3adb422026-04-10WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
BonicaEaseX Colorless Roll-On Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co.,Ltdacf460b4-1b41-4b30-a74a-6c3613119d8e2026-04-10WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
BonicaEaseX Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co.,Ltd4d84b4fb-8f55-4b2b-b261-858edb7f31442026-04-10WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
Topical Hemorrhoid Relief GelMENTHOL, UNSPECIFIED FORMYantai Aien Biotechnology Co., Ltd.4d6e6667-ab1c-de7c-e063-6294a90a0b9b2026-03-20WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
CVS Health Pain Relief FootMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.0f646876-69d0-49db-ade2-2b3eb26dd3992026-03-16WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
Still StandingMENTHOL, UNSPECIFIED FORMNatural Essentials Inc.66974aaf-c82f-4fe9-bfb3-3430b80ac9f22026-03-02WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
daily solutions Ice Blue AnalgesicMENTHOL, UNSPECIFIED FORMGarcoa, Inc.4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e62026-02-06WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM
FEMININE PAIN RELIEFMENTHOL, UNSPECIFIED FORMBeYou Together Ltd9636b973-fe7e-481e-a6e9-8070347c08832025-12-31WarningsName fallback
generic name: MENTHOL, UNSPECIFIED FORM

Reported adverse events (FAERS/openFDA)#

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