Raw Heat
FDA Label NDC 55413-2501

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raw Health International, Llc for the product Raw Heat (NDC 55413-2501). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, otc - when using, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Menthol 3.5%

Purpose

Pain Reliever

Uses

Temporarily relieves minor pain associated with: muscle sprains, muscle strains, neck/back aches/pains, sore joints, arthritis, cramps and bruises.

Warnings

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

Otc - 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.

Otc - When Using

When using this product: Use only as directed. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not bandage tightly.

Otc - Do Not Use

Do not use with a heating pad or other ointments, creams, sprays or liniments. Do not apply to irritated skin. Wash hands thoroughly after each application.

Otc - Stop Use

Stop use and ask a health professional if condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, or if irritation occurs. If pregnant or breast feeding ask a health care professional before use. Store at room temperature.

Directions

For adults and children 6 years of age and older: Shake well. Clean skin. Apply a liberal amount of gel directly on the skin over the affected area until absorbed into skin. Repeat as necessary, but not more than 4 times daily. May also be applied before or after activity. For children under 6 years of age, consult a health care professional.

Inactive Ingredients

Aloe Barbadensis (Aloe) Leaf Gel, SDA 38B, Glycerin, Xanthan Gum, Gaultheria Procumbens (Wintergreen) Leaf Oil, Cinnamomum Cassia (Cassia) Oil, Dehydroxyxanthan Gum, Cinnamomum Camphora (Camphor) Bark Oil, Organic Chamomilla Recutita (Matricaria), Organic Symphytum Officinalis (Comfrey)

RAW Health International, LLC
91 Ft. Couch Road-Pittsburgh, PA 15241
www.rawhealthintl.com
Ph: 1-888-RAW-HLTH

Principal Display Panel – 3 Oz. Bottle

RAW
RAW HEALTH INTERNATIONAL

HEAT

The All-Natural
Warming Pain Reliever

Muscle Strains,
Joint Sprains, Neck/Back Aches,
Pains and Much More…

3 fl OZ / 89 mL

www.rawhealthintl.com
Also Try RAW-ICE for cooling pain relief

Principal Display Panel – 3 Oz. Bottle (Raw02 0001 01)

Principal Display Panel – 3 Oz. Bottle (Raw02 0001 01)

* Please review the disclaimer below.