Fast Freeze Ndc 66902-116 Drug Facts

Fast Freeze Ndc 66902-116 Drug Facts
SPL v4
SPL
SPL Set ID 15a26af1-ca5a-40fc-a411-6c0e8ae18fbb
Route
TOPICAL
Published
Effective Date 2021-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (33 mg)
Inactive Ingredients
Aloe Vera Leaf Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Camphor (synthetic) .alpha.-tocopherol Acetate Isopropyl Alcohol Methylparaben Ilex Paraguariensis Leaf Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-31
Description

Menthol 3.5%

Purpose

Cooling Pain Relief

Medication Information

Purpose

Cooling Pain Relief

Description

Menthol 3.5%

Uses

Temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backache
  • Arthritis
  • Strains
  • Sprains
Warnings
  • For external use only
  • Flammable
  • Keep away from excessive heat or open flame
Directions

Adults/Children 2 years and older:

  • Roll on the affected area not more than 3 to 4 times daily
  • Shake well before use

Children under 2 years old:Consult a physician.

Do Not Use
  • With heating pad or device
  • With ointments, creams, sprays or liniments
  • On wounds, damaged skin or irritated skin
Questions?

Call 317-228-1144 or visit www.Bell-Horn.com or www.fastfreeze.com

Other Information
  • Replace cap after use
  • Store in a cool, dry place
Active Ingredients

Menthol 3.5%

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Carbomer, dl-alpha Tocopheryl Acetate, dl-Camphor, Isopropyl Alcohol, Mate (Ilex Paraguariensis) Extract, Methylparaben, Triethanolamine, Water.

When Using This Product
  • Avoid contact with eyes or mucous membranes
  • Do not bandage tightly
Stop Use and Ask A Doctor If
  • Condition worsens
  • Symptoms persist for more than 7 days or clear up then reoccur again within a few days
  • Irritation develops
Ask A Doctor Before Use If You
  • Have sensitive skin
  • Are pregnant or breastfeeding
Keep Out of Reach of Children.

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

Principal Display Panel 120 Ml Tube Label

FAST FREEZE ®

Naturally

Cool

Pain Relieving Gel

Helps to relieve

  • Sore muscles
  • Strains & sprains
  • Joint pain
  • Invigorating, cooling menthol
  • Greaseless & stain-free
  • Natural ingredients include

    Vitamin E, Aloe & Ilex

Net wt. 4 oz (113 g)

Principal Display Panel 89 Ml Container Label

FAST FREEZE®

Naturally

Cool

Pain Relieving Roll-On

Helps to relieve

  • Sore muscles
  • Strains & sprains
  • Joint pain
  • Invigorating, cooling menthol
  • Greaseless & stain-free
  • Natural ingredients include

    Vitamin E, Aloe & Ilex

3 oz (89 mL)

Structured Label Content

Uses

Temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backache
  • Arthritis
  • Strains
  • Sprains
Purpose

Cooling Pain Relief

Warnings
  • For external use only
  • Flammable
  • Keep away from excessive heat or open flame
Directions

Adults/Children 2 years and older:

  • Roll on the affected area not more than 3 to 4 times daily
  • Shake well before use

Children under 2 years old:Consult a physician.

Do Not Use (Do not use)
  • With heating pad or device
  • With ointments, creams, sprays or liniments
  • On wounds, damaged skin or irritated skin
Questions?

Call 317-228-1144 or visit www.Bell-Horn.com or www.fastfreeze.com

Other Information (Other information)
  • Replace cap after use
  • Store in a cool, dry place
Active Ingredients (Active ingredients)

Menthol 3.5%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Extract, Carbomer, dl-alpha Tocopheryl Acetate, dl-Camphor, Isopropyl Alcohol, Mate (Ilex Paraguariensis) Extract, Methylparaben, Triethanolamine, Water.

When Using This Product (When using this product)
  • Avoid contact with eyes or mucous membranes
  • Do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens
  • Symptoms persist for more than 7 days or clear up then reoccur again within a few days
  • Irritation develops
Ask A Doctor Before Use If You (Ask a doctor before use if you)
  • Have sensitive skin
  • Are pregnant or breastfeeding
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.

Principal Display Panel 120 Ml Tube Label (Principal Display Panel - 120 mL Tube Label)

FAST FREEZE ®

Naturally

Cool

Pain Relieving Gel

Helps to relieve

  • Sore muscles
  • Strains & sprains
  • Joint pain
  • Invigorating, cooling menthol
  • Greaseless & stain-free
  • Natural ingredients include

    Vitamin E, Aloe & Ilex

Net wt. 4 oz (113 g)

Principal Display Panel 89 Ml Container Label (Principal Display Panel - 89 mL Container Label)

FAST FREEZE®

Naturally

Cool

Pain Relieving Roll-On

Helps to relieve

  • Sore muscles
  • Strains & sprains
  • Joint pain
  • Invigorating, cooling menthol
  • Greaseless & stain-free
  • Natural ingredients include

    Vitamin E, Aloe & Ilex

3 oz (89 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:47.903745 · Updated: 2026-03-14T23:09:45.619768