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Raw Ice by Rescue Dog Health

Dosage form: gel
Ingredients: menthol 3.5mg in 1L
Labeler: Rescue Dog Health
NDC Code: 69381-2500

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, Dehydroxanthan Gum, Glycerin, Mentha Piperita (Peppermint) Oil, 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™

ICE

100% Natural
Pain Relief

For arthritis, muscle
and joint pain

ROLL-ON GEL

3 fl OZ/89 mL

Principal Display Panel - Bottle Label

RAW™

ICE

100% Natural
Pain Relief

For arthritis,
muscle and
joint pain

GEL

4 fl OZ/118 mL

Principal Display Panel - Bottle Label

RAW™

ICE

100% Natural
Pain Relief

For arthritis, muscle
and joint pain

GEL

32 fl OZ/946 mL

RAW ICE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69381-2500
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 
peppermint oil 
xanthan gum 
camphor oil 
matricaria recutita 
symphytum uplandicum leaf 
Packaging
#Item CodePackage Description
1NDC:69381-2500-10.089 L in 1 BOTTLE
2NDC:69381-2500-20.118 L in 1 BOTTLE
3NDC:69381-2500-30.946 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(69381-2500)

 
Rescue Dog Health

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Medically reviewed on Dec 18, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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