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

Description

Drug Facts

Purpose

Cooling Pain Relief


Medication Information

Purpose

Cooling Pain Relief

Description

Drug Facts

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Sprains
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)

Warnings
  • For external use only
  • Flammable
  • Keep away from excessive heat or open flame
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 (Aloe Vera) Leaf Extract, Carbomer, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Methylparaben, Tocopherol (Vitamin E) Acetate, 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.

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

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Sprains
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)

Purpose

Cooling Pain Relief

Warnings
  • For external use only
  • Flammable
  • Keep away from excessive heat or open flame
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 (Aloe Vera) Leaf Extract, Carbomer, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Methylparaben, Tocopherol (Vitamin E) Acetate, 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.

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)