a96e3e41-871c-4cf3-93b6-af2a6246ded8

SPL v4
SPL
SPL Set ID a96e3e41-871c-4cf3-93b6-af2a6246ded8
Route
topical
Published
Effective Date 2019-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (35 mg)
Inactive Ingredients
aloe vera leaf carbomer interpolymer type a (allyl sucrose crosslinked) ilex paraguariensis leaf isopropyl alcohol methylparaben .alpha.-tocopherol acetate trolamine water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2013-01-01
Purpose

Cooling Pain Relief

Description

Drug Facts

Medication Information

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

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

  • Simple backache
  • Arthritis
  • Strains
  • Sprains
Purpose

Cooling Pain Relief

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

Aloe Barbadensis (Aloe Vera) Leaf Extract, Carbomer, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Methylparaben, Tocopherol (Vitamin E) Acetate, Triethanolamine, Water.

Description

Drug Facts

Questions?

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

Section 42229-5

Drug Facts

Section 51945-4

Principal Display Panel – Bottle 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 & llex

………………………………….

3 oz (89 mL)

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

Menthol 3.5%

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.

Adults/children 2 Years and Older:
  • Roll on the affected area not more than 3 to 4 times daily
  • Shake well before use

Structured Label Content

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

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

  • Simple backache
  • Arthritis
  • Strains
  • Sprains
Purpose

Cooling Pain Relief

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

Aloe Barbadensis (Aloe Vera) Leaf Extract, Carbomer, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Methylparaben, Tocopherol (Vitamin E) Acetate, Triethanolamine, Water.

Questions?

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

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

Principal Display Panel – Bottle 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 & llex

………………………………….

3 oz (89 mL)

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

Menthol 3.5%

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.

Adults/children 2 Years and Older: (Adults/Children 2 years and older:)
  • Roll on the affected area not more than 3 to 4 times daily
  • Shake well before use

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:40.848506 · Updated: 2026-03-14T23:03:51.620726