Freeze It menthol 3.5% Gel

Freeze It menthol 3.5% Gel
SPL v1
SPL
SPL Set ID de8d8007-5718-4fb4-a8c6-4650d2ca9c8f
Route
TOPICAL
Published
Effective Date 2025-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3.5 g)
Inactive Ingredients
Aloe Vera Leaf Indian Frankincense Camphor (synthetic) Carbomer Homopolymer, Unspecified Type Dimethyl Sulfone Fd&c Yellow No. 5 Fd&c Blue No. 1 Glucosamine Hydrochloride Ilex Paraguariensis Leaf Isopropyl Alcohol Tetrahydrodiferuloylmethane .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-05

Description

Menthol 3.5%

Purpose

Pain Relieving Gel


Medication Information

Purpose

Pain Relieving Gel

Description

Menthol 3.5%

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache 
  • arthritis 
  • strains
  • bruises 
  • sprains
Section 51945-4

Section 53414-9

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

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame

Directions
  • 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
Active Ingredient

Menthol 3.5%

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

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.

When Using This Product:
  • 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
  • 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
Keep Out of Reach of Children.

 If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache 
  • arthritis 
  • strains
  • bruises 
  • sprains
Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purpose

Pain Relieving Gel

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame

Directions
  • 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
Active Ingredient

Menthol 3.5%

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

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.

When Using This Product: (When using this product:)
  • 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 (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
  • arthritic pain persists for more than 10 days, or redness is present or in conditions affecting children under 12 years of age
Keep Out of Reach of Children. (Keep out of reach of children.)

 If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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