Arctic Heat

Arctic Heat
SPL v8
SPL
SPL Set ID 402df5c1-b8cb-17a2-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (11.2 g) Menthol (2.24 g)
Inactive Ingredients
Niacinamide Cetostearyl Alcohol Cetearyl Glucoside Glyceryl Monostearate Water Peppermint Oil C13-14 Isoparaffin Dehydroacetic Acid Peg-100 Stearate Tabasco Pepper Allantoin Phenoxyethanol Benzoic Acid Laureth-7 Stearic Acid Sodium Acryloyldimethyltaurate-acrylamide Copolymer (1:1; 90000-150000 Mpa.s) Emu Oil Eucalyptus Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-09-17
Description

Menthol 2% Methyl Salicylate 10%

Purpose

Topical Analgesic Topical Analgesic

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporarily relieves minor aches and pains of muscle and joints due to: arthritis, simple backache, sprains, strains and bruises

Purpose

Topical Analgesic

Topical Analgesic

Dosage and Administration

Directions

Adults and children 12 years of age and

older: Apply directly to affected area no more than 3 to 4 times daily.

Description

Menthol 2% Methyl Salicylate 10%

Section 50566-9

  • Conditions worsen
  • Symptoms last for more than 7 days or clear up and occur again within a few days
  • A rash or irritation develops
Section 53413-1

Manufactured by:

Renu Labs Inc.

Ivyland, PA 18974

www.RenuLabs.com

Arctic Heat

Dual Active Botanical Warming Formula with Emu Oil

Arctic Heat Tube

Active Ingredients

Menthol 2%

Methyl Salicylate 10%

Inactive Ingredients

Allantoin, Benzoic Acid, C13-14 Isoparaffin, Capsicum Frutescens Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Dehydroacetic Acid, Deionized Water, Emu Oil, Eucalyptus Globulus Leaf Oil, Glyceryl Stearate, Laureth-7, Mentha Piperita (Peppermint) Oil, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Stearic Acid.

When Using This Product

  • Do not apply to wounds or damaged skin
  • Do not bandage tightly
  • Do not use in or near eyes; if product gets into eyes rinse thoroughly with water
  • Do not use with an electric heating pad
If Pregnant Or Breast Feeding,

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

Indications and Usage (34067-9)

Temporarily relieves minor aches and pains of muscle and joints due to: arthritis, simple backache, sprains, strains and bruises

Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age and

older: Apply directly to affected area no more than 3 to 4 times daily.

Warnings and Precautions (34071-1)

For external use only

Section 50566-9 (50566-9)

  • Conditions worsen
  • Symptoms last for more than 7 days or clear up and occur again within a few days
  • A rash or irritation develops
Section 53413-1 (53413-1)

Manufactured by:

Renu Labs Inc.

Ivyland, PA 18974

www.RenuLabs.com

Purpose (PURPOSE)

Topical Analgesic

Topical Analgesic

Arctic Heat (ARCTIC HEAT)

Dual Active Botanical Warming Formula with Emu Oil

Arctic Heat Tube (ARCTIC HEAT TUBE)

Active Ingredients (ACTIVE INGREDIENTS)

Menthol 2%

Methyl Salicylate 10%

Inactive Ingredients

Allantoin, Benzoic Acid, C13-14 Isoparaffin, Capsicum Frutescens Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Dehydroacetic Acid, Deionized Water, Emu Oil, Eucalyptus Globulus Leaf Oil, Glyceryl Stearate, Laureth-7, Mentha Piperita (Peppermint) Oil, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Stearic Acid.

When Using This Product (When using this product)

  • Do not apply to wounds or damaged skin
  • Do not bandage tightly
  • Do not use in or near eyes; if product gets into eyes rinse thoroughly with water
  • Do not use with an electric heating pad
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:59.289584 · Updated: 2026-03-14T23:10:09.220745