FREEZE IT Menthol 3.5% Gel

Manufacturer
LiquidCapsule Manufacturing LLC
Effective date
2025-06-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:26

Label at a glance#

ProductFREEZE IT Menthol
Active ingredientMENTHOL
Label structure12 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: simple backache  arthritis  strains bruises  sprains

Dosage and administration

adults and children 12 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily children under 2 years of age: consult a physician wash hands after use with cool water

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 3.5%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Gel

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves 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

  • use only 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 of the skin
  • 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, or redness is present or in conditions affecting children under 12 years of age

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of 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 12 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
  • wash hands after use with cool water

Other information

OTHER SAFETY INFORMATION

  • store at 20–25ºC (68–77ºF)
  • store in a cool dry place away from direct sunlight

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Boswellia Serrata Extract (as B-NHIBITX™), Camphor, Carbomer, Dimethyl Sulfone (as OptiMSM®), FD&C Yellow #5, FD&C Blue #1, Glucosamine HCl, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Methylparaben, Tetrahydrodiferuloylmethane,
Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freeze It 4oz Tube 10-25-24Freeze It 4oz Tube 10-25-24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808955menthol 3.5 % Topical GelPSN1
808955menthol 0.035 MG/MG Topical GelSCD1
808955menthol 3.5 % Topical GelSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71726-004-02FREEZE IT Menthol113.4 g in 1 TUBEGEL113.41

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71726-00471726-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FREEZE IT MentholMENTHOLLiquidCapsule Manufacturing LLCde8d8007-5718-4fb4-a8c6-4650d2ca9c8f2025-06-05WarningsExact identifier
ndc (package): 71726-004-02
ndc (product): 71726-004
ndc11 (package): 71726000402
spl id: 6e80d075-fdc1-448f-9e11-7a6980359ef7
spl set id: de8d8007-5718-4fb4-a8c6-4650d2ca9c8f

Reported adverse events (FAERS/openFDA)#

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