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

Purpose

Topical Analgesic Topical Analgesic

Description

Menthol 2% Methyl Salicylate 10%


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.

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.

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%

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

Warnings and Precautions (34071-1)

For external use only

Indications and Usage (34067-9)

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

Purpose (PURPOSE)

Topical Analgesic

Topical Analgesic

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.

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.

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

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%

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

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