Your browser does not support JavaScript! RAW HEAT (MENTHOL) LIQUID [RAW HEALTH INTERNATIONAL, LLC]
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RxNorm Names

RAW HEAT (menthol) liquid
[Raw Health International, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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.

Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

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.

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.

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

Questions or comments:

Email us at: info@rawhealthintl.com

MSRP $14.99

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
RAW HEAT 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55413-2501
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
menthol (menthol) menthol34.86 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
glycerin 
xanthan gum 
methyl salicylate 
chinese cinnamon oil 
camphor oil 
matricaria recutita 
symphytum uplandicum leaf 
Packaging
#Item CodePackage Description
1NDC:55413-2501-10.089 L in 1 BOTTLE
2NDC:55413-2501-20.118 L in 1 BOTTLE
3NDC:55413-2501-30.004 L in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/15/2013
Labeler - Raw Health International, LLC (014982454)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(55413-2501)

Revised: 01/2013
Document Id: d851dba4-b008-4343-a4ea-66dd8a981177
Set id: cbad9b68-12e8-4766-893b-a0ed6b1f0484
Version: 2
Effective Time: 20130130
 
Raw Health International, LLC

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