fast freeze ndc 66902-015

SPL v6

SPL

SPL Set ID d8c42c8d-6ce0-43bf-b165-41979f3d8f79

Route

topical

Published

Effective Date 2025-08-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

menthol (100 mg)

Inactive Ingredients

aloe vera leaf ilex paraguariensis leaf isopropyl alcohol .alpha.-tocopherol acetate water

Identifiers & Packaging

Marketing Status

otc monograph drug completed Since 2013-01-01 Until 2025-07-01

Purpose

Cooling Pain Relief

Description

Drug Facts

Medication Information

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)

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, Ilex Paraguariensis Leaf Extract,SDA-39c Alcohol, Tocopherol (Vitamin E) Acetate, 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

Continuous Spray

Helps to relieve

Sore muscles
Strains & sprains
Joint pain

………………………………….

Invigorating cooling menthol
Greaseless & stain-free
Natural ingredients include

Vitamin E, Aloe & llex

………………………………….

4 oz (118 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 10%

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:

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

Principal Display Panel Pump Bottle Label 4 Oz (118 Ml)

Fast Freeze®

Naturally Cool

Pain Relieving 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

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)

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, Ilex Paraguariensis Leaf Extract,SDA-39c Alcohol, Tocopherol (Vitamin E) Acetate, 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

Continuous Spray

Helps to relieve

Sore muscles
Strains & sprains
Joint pain

………………………………….

Invigorating cooling menthol
Greaseless & stain-free
Natural ingredients include

Vitamin E, Aloe & llex

………………………………….

4 oz (118 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 10%

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:)

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

Principal Display Panel Pump Bottle Label 4 Oz (118 Ml) (Principal Display Panel - Pump Bottle Label 4 oz (118 mL))

Fast Freeze®

Naturally Cool

Pain Relieving 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

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ILEX PARAGUARIENSIS LEAF", "unii": "1Q953B4O4F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Strains Sprains", "42229-5": "Drug Facts", "51945-4": "Principal Display Panel – Bottle 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 & llex …………………………………. 4 oz (118 mL)", "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)", "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 (Aloe Vera) Leaf Extract, Ilex Paraguariensis Leaf Extract,SDA-39c Alcohol, Tocopherol (Vitamin E) 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.", "Adults/Children 2 years and older:": "Spray on the affected area not more than 3 to 4 times daily Shake well before use", "Principal Display Panel - Pump Bottle Label 4 oz (118 mL)": "Fast Freeze® Naturally Cool Pain Relieving 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)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:46.287575 · Updated: 2026-03-14T23:09:44.239716