41b2e9a0-818d-4188-8c9d-8ff7c0d0519b

Drug Facts

Composition & Product

Active Ingredients

menthol (35 mg)

Inactive Ingredients

aloe vera leaf camphor (synthetic) carbomer homopolymer type c (allyl pentaerythritol crosslinked) ilex paraguariensis leaf isopropyl alcohol methylparaben trolamine water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2017-12-01

Medication Information

Warnings

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

Uses

Temporary relief from minor aches and pains associated with:

Tendonitis
Strains
Sprains
Sore muscles
Joint discomfort
Arthritis

Purpose

Cooling Pain Relief

Other Information

Replace cap after use
Store in a cool, dry place.

Description

ICY FREEZE COOLING PAIN RELIEF Drug Facts

Section 42229-5

ICY FREEZE COOLING PAIN RELIEF

Drug Facts

Section 50565-1

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

Section 51727-6

Non-medicinal ingredients Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, dl-alpha Tocopheryl acetate, Purified Water, dl-Camphor, Carbomer, Isopropyl alcohol, Methylparaben, Triethanolamine.

MADE IN USA for Healer Health LLC

Zionsville, Indiana 46077 TM Reg'd 85140-L

ICYFREEZE.COM

Section 51945-4

Principal Display Panel - Icy Freeze 3oz Gel Pump

FREEZES PAIN

THERAPUTIC 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

GEL

4 FL OZ (120 mL)

Do Not Use

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

Active Ingredient

Menthol 3.5%

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

Directions 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

Structured Label Content

Warnings

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

Uses

Temporary relief from minor aches and pains associated with:

Tendonitis
Strains
Sprains
Sore muscles
Joint discomfort
Arthritis

Purpose

Cooling Pain Relief

Other Information (Other information)

Replace cap after use
Store in a cool, dry place.

Section 42229-5 (42229-5)

ICY FREEZE COOLING PAIN RELIEF

Drug Facts

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Non-medicinal ingredients Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, dl-alpha Tocopheryl acetate, Purified Water, dl-Camphor, Carbomer, Isopropyl alcohol, Methylparaben, Triethanolamine.

MADE IN USA for Healer Health LLC

Zionsville, Indiana 46077 TM Reg'd 85140-L

ICYFREEZE.COM

Section 51945-4 (51945-4)

Principal Display Panel - Icy Freeze 3oz Gel Pump

FREEZES PAIN

THERAPUTIC 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

GEL

4 FL OZ (120 mL)

Do Not Use (Do not use)

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

Active Ingredient (Active ingredient)

Menthol 3.5%

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

Directions Adults/children 2 Years and Older: (Directions 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

Advanced Ingredient Data

[{"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "35", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "4Q93RCW27E", "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": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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": "ICY FREEZE COOLING PAIN RELIEF Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Non-medicinal ingredients Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, dl-alpha Tocopheryl acetate, Purified Water, dl-Camphor, Carbomer, Isopropyl alcohol, Methylparaben, Triethanolamine. MADE IN USA for Healer Health LLC Zionsville, Indiana 46077 TM Reg'd 85140-L ICYFREEZE.COM", "51945-4": "Principal Display Panel - Icy Freeze 3oz Gel Pump FREEZES PAIN THERAPUTIC 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 GEL 4 FL OZ (120 mL)", "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", "Active ingredient": "Menthol 3.5%", "Other information": "Replace cap after use Store in a cool, dry place.", "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", "Directions 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"}

41b2e9a0-818d-4188-8c9d-8ff7c0d0519b

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information