Icequake Cold'n Hot

Icequake Cold'n Hot
SPL v1
SPL
SPL Set ID 09774bab-f366-412f-a3fc-26f00f44928e
Route
TOPICAL
Published
Effective Date 2019-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Butylene Glycol Carboxymethylcellulose Sodium Glycerin Diethylene Glycol Edetate Disodium Anhydrous Methylparaben Polyacrylic Acid (250000 Mw) Polysorbate 80 Propylparaben Water Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-03-01

Description

For External Use Only.

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

For External Use Only.

Section 51945-4

Southern Sales Services Inc

Pembroke Pines, FL 33332

Warnings

For External Use Only.

Active Ingredient

Active Ingredient ...............................................................................................Purpose

Menthol 5%...............................................................................................Topical Analgesic

Inactive Ingredient

Aluminium glycinate,1,3-buthylene Glycol, Carboxymethylcellulose Sodium, Concentrated Glycerin, diethylene Glycolmonoethyl Ether, Disodium Edetate, Methyl Parahydroxybenzoate, Polyacrylic Acid Solution, Polysorbate 80, Propyl Parahydroxybenzoate, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Oxide

Indications & Usage

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis<br />■ muscle strains ■ muscle sprains ■ bruises ■ cramps

Dosage & Administration

Adults and children 12 years of age and over: Carefully remove backing from patch.

Apply one patch to affected area

Repeat as necessary, but no more than 4 times daily.

Children under 12 years of age: Ask a doctor.

When Using This Product

Use only as directed

■ Do not bandage tightly.

■ Do not use a heating pad.

■ Avoid contact with eyes and mucous membranes.

■ Don’t apply to wounds or damaged skin.

■ Do not use if you are alergic to any ingredients of this product.

Stop Use and Ask A Doctor

■ If condition worsens

■ If symptoms persist for more than 7 days or clear up and occur again within a few days.

■ If redness is present

■ If irritation develops

If Pregnant Or Breastfeeding

ask a health professional before use.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Section 51945-4 (51945-4)

Southern Sales Services Inc

Pembroke Pines, FL 33332

Purpose (PURPOSE)

Topical Analgesic

Warnings (WARNINGS)

For External Use Only.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient ...............................................................................................Purpose

Menthol 5%...............................................................................................Topical Analgesic

Inactive Ingredient (INACTIVE INGREDIENT)

Aluminium glycinate,1,3-buthylene Glycol, Carboxymethylcellulose Sodium, Concentrated Glycerin, diethylene Glycolmonoethyl Ether, Disodium Edetate, Methyl Parahydroxybenzoate, Polyacrylic Acid Solution, Polysorbate 80, Propyl Parahydroxybenzoate, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Oxide

Indications & Usage (INDICATIONS & USAGE)

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis<br />■ muscle strains ■ muscle sprains ■ bruises ■ cramps

Dosage & Administration (DOSAGE & ADMINISTRATION)

Adults and children 12 years of age and over: Carefully remove backing from patch.

Apply one patch to affected area

Repeat as necessary, but no more than 4 times daily.

Children under 12 years of age: Ask a doctor.

When Using This Product (When using this product)

Use only as directed

■ Do not bandage tightly.

■ Do not use a heating pad.

■ Avoid contact with eyes and mucous membranes.

■ Don’t apply to wounds or damaged skin.

■ Do not use if you are alergic to any ingredients of this product.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

■ If condition worsens

■ If symptoms persist for more than 7 days or clear up and occur again within a few days.

■ If redness is present

■ If irritation develops

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use.

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.


Advanced Ingredient Data


Raw Label Data

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