Rsd Emu Oil Pain Therapy

Rsd Emu Oil Pain Therapy
SPL v1
SPL
SPL Set ID c29c250f-39be-7bef-e053-2a95a90a3d6e
Route
TOPICAL
Published
Effective Date 2021-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-05-14

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 43683-2

No major changes to any section.

This is a simple product name change.

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 51945-4

RANCHO SAN DIEGO PAIN RELIEF TUBE

Section 53413-1

Manufactured by:

Renu Labs Inc.

Ivyland, PA 18974

www.RenuLabs.com

Arctic Heat

Dual Active Botanical Warming Formula with Emu Oil

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 43683-2 (43683-2)

No major changes to any section.

This is a simple product name change.

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 51945-4 (51945-4)

RANCHO SAN DIEGO PAIN RELIEF TUBE

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

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

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