Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 28fdb049-b297-4358-9447-7d69ba879702

Route

TOPICAL

Published

Effective Date 2020-05-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Menthol, Unspecified Form (100 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 2020-05-14

Description

NDC 66902-168-40

Purpose

Cooling Pain Relief

Medication Information

Purpose

Cooling Pain Relief

Description

NDC 66902-168-40

Uses

Temporary relief from minor aches and pains associated with:

Tendonitis
Strains
Sprains
Sore muscles
Joint discomfort
Arthritis

Section 42229-5

NDC 66902-168-40

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

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

Do Not Use

With heating pad or device
With creams, ointments, sprays or liniments
On wounds damaged skin or irritated skin

Questions?

Call 317-689-7711

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), dl-Camphor, SDA-39C Alcohol, dl-alpha Tocopheryl acetate, Purified Water.

When Using This Product

Avoid contact with eyes or mucous membranes
Do not bandage tightly

Children Under 2 Years Old:

Application should be supervised by an adult.

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

Adults/children 2 Years and Older

Apply to the affected area not more than 3 to 4 times daily; Rub into skin until solution vanishes

Principal Display Panel – 4 Oz Can Label

THERAPEUTIC PAIN RELIEF

Greaseless and stain free with Aloe, Vitamin E and Ilex

NATURAL INGREDIENTS • SOOTHING MENTHOL • VANISHING SCENT

ICY FREEZE

COOLING PAIN RELIEF

FOR TENDONITIS, ARTHRITIS. SPRAINS AND STRAINS

FREEZES PAIN

360° CONTINUOUS SPRAY

4 FL OZ (120 mL)

Structured Label Content

Uses

Temporary relief from minor aches and pains associated with:

Tendonitis
Strains
Sprains
Sore muscles
Joint discomfort
Arthritis

Section 42229-5 (42229-5)

NDC 66902-168-40

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

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 creams, ointments, sprays or liniments
On wounds damaged skin or irritated skin

Questions?

Call 317-689-7711

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), dl-Camphor, SDA-39C Alcohol, dl-alpha Tocopheryl acetate, Purified Water.

When Using This Product (When using this product)

Avoid contact with eyes or mucous membranes
Do not bandage tightly

Children Under 2 Years Old: (Children under 2 years old:)

Application should be supervised by an adult.

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

Adults/children 2 Years and Older (Adults/Children 2 years and older)

Apply to the affected area not more than 3 to 4 times daily; Rub into skin until solution vanishes

Principal Display Panel – 4 Oz Can Label (Principal Display Panel – 4 oz Can Label)

THERAPEUTIC PAIN RELIEF

Greaseless and stain free with Aloe, Vitamin E and Ilex

NATURAL INGREDIENTS • SOOTHING MENTHOL • VANISHING SCENT

ICY FREEZE

COOLING PAIN RELIEF

FOR TENDONITIS, ARTHRITIS. SPRAINS AND STRAINS

FREEZES PAIN

360° CONTINUOUS SPRAY

4 FL OZ (120 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": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "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, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporary relief from minor aches and pains associated with: Tendonitis Strains Sprains Sore muscles Joint discomfort Arthritis", "42229-5": "NDC 66902-168-40", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose": "Cooling Pain Relief", "Warnings": "For external use only Flammable Keep away from excessive heat or open flame", "Do not use": "With heating pad or device With creams, ointments, sprays or liniments On wounds damaged skin or irritated skin", "Questions?": "Call 317-689-7711", "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), dl-Camphor, SDA-39C Alcohol, dl-alpha Tocopheryl acetate, Purified Water.", "When using this product": "Avoid contact with eyes or mucous membranes Do not bandage tightly", "Children under 2 years old:": "Application should be supervised by an adult.", "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", "Adults/Children 2 years and older": "Apply to the affected area not more than 3 to 4 times daily; Rub into skin until solution vanishes", "Principal Display Panel – 4 oz Can Label": "THERAPEUTIC PAIN RELIEF Greaseless and stain free with Aloe, Vitamin E and Ilex NATURAL INGREDIENTS • SOOTHING MENTHOL • VANISHING SCENT ICY FREEZE COOLING PAIN RELIEF FOR TENDONITIS, ARTHRITIS. SPRAINS AND STRAINS FREEZES PAIN 360° CONTINUOUS SPRAY 4 FL OZ (120 mL)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:40.794463 · Updated: 2026-03-14T23:09:34.496634