Raw Heat by Rescue Dog Health / Safetec of America, Inc. RAW HEAT- menthol gel

Raw Heat by

Drug Labeling and Warnings

Raw Heat by is a Otc medication manufactured, distributed, or labeled by Rescue Dog Health, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

RAW HEAT 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69381-2501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A)	menthol	3.5 mg  in 1 L

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
glycerin (UNII: PDC6A3C0OX)
xanthan gum (UNII: TTV12P4NEE)
methyl salicylate (UNII: LAV5U5022Y)
chinese cinnamon oil (UNII: A4WO0626T5)
camphor oil (UNII: 75IZZ8Y727)
matricaria recutita (UNII: G0R4UBI2ZZ)
symphytum uplandicum leaf (UNII: D05HXK6R3G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69381-2501-1	0.089 L in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69381-2501-2	0.118 L in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69381-2501-3	0.946 L in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/18/2014

Labeler - Rescue Dog Health (079558153)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(69381-2501)