SPL v2
SPL
SPL Set ID 998a4824-9ed9-4fe0-b45b-72e52861fcd3
Route
TOPICAL
Published
Effective Date 2021-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (89 mg)
Inactive Ingredients
Aloe Vera Leaf Ilex Paraguariensis Leaf Camphor (synthetic) Alcohol .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-19

Description

NDC 66902-115-04 Drug Facts

Purpose

Cooling Pain Relief


Medication Information

Purpose

Cooling Pain Relief

Description

NDC 66902-115-04 Drug Facts

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Sprains
Section 42229-5

NDC 66902-115-04

Drug Facts

Warnings
  • For external use only
  • Flammable
  • Keep away from excessive heat or open flame
  • Avoid spraying in eyes
  • Contents under pressure. Do not puncture or incinerate container.

    Do not store at temperature above 120°F (48°C)
Directions

Adults/Children 2 years and older:

  • Spray 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 10%

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, dl-Camphor, SDA-39C Alcohol, dl-alphaTocopheryl acetate, 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 – 118 Ml Can Label

FAST FREEZE ®

Naturally Cool

Pain Relieving

Continuous Spray

Helps to relieve

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

4 oz (118 mL)


Structured Label Content

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Sprains
Section 42229-5 (42229-5)

NDC 66902-115-04

Drug Facts

Purpose

Cooling Pain Relief

Warnings
  • For external use only
  • Flammable
  • Keep away from excessive heat or open flame
  • Avoid spraying in eyes
  • Contents under pressure. Do not puncture or incinerate container.

    Do not store at temperature above 120°F (48°C)
Directions

Adults/Children 2 years and older:

  • Spray 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 10%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, dl-Camphor, SDA-39C Alcohol, dl-alphaTocopheryl acetate, 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 – 118 Ml Can Label (Principal Display Panel – 118 mL Can Label)

FAST FREEZE ®

Naturally Cool

Pain Relieving

Continuous Spray

Helps to relieve

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

4 oz (118 mL)


Advanced Ingredient Data


Raw Label Data

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