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Raw Heat by Rescue Dog Health

Medically reviewed on December 18, 2017

Dosage form: gel
Ingredients: menthol 3.5mg in 1L
Labeler: Rescue Dog Health
NDC Code: 69381-2501

Disclaimer: 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 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, Cinnamomum Camphora (Camphor) Bark Oil, Cinnamon Cassia (Cassia) Oil, Dehydroxanthan Gum, Gaultheria Procumbens (wintergreen) Leaf Oil, Glycerin, Organic Chamomilla Recutita (Matricaria) Flower Extract, Organic Symphytum Officinale (Comfrey), SDA 38B, Xanthan Gum

Rescue Health, LLC
Bentonville, AR 72712

www.rawhealthintl.com
Ph: 1-888-RAW-HLTH

Questions or comments:

Email us at: info@rawhealthintl.com

Principal Display Panel - Bottle Label

RAW™

HEAT

100% Natural
Pain Relief

For arthritis, muscle
and joint pain

ROLL-ON GEL

3 fl OZ/89 mL

Principal Display Panel - Bottle Label

RAW™

HEAT

100% Natural
Pain Relief

For arthritis,
muscle and
joint pain

GEL

4 fl OZ/118 mL

Principal Display Panel - Bottle Label

RAW™

HEAT

100% Natural
Pain Relief

For arthritis, muscle
and joint pain

GEL

32 fl OZ/946 mL

RAW HEAT 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69381-2501
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
menthol (menthol) menthol3.5 mg  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:69381-2501-10.089 L in 1 BOTTLE
2NDC:69381-2501-20.118 L in 1 BOTTLE
3NDC:69381-2501-30.946 L in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/18/2014
Labeler - Rescue Dog Health (079558153)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(69381-2501)

 
Rescue Dog Health

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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