Raw Ice (Menthol) Liquid [Raw Health International, Llc] -

RAW ICE (MENTHOL) LIQUID [RAW HEALTH INTERNATIONAL, LLC]
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NDC	55413-2500-1, 55413-2500-2, 55413-2500-3
Set ID	ab1dbc12-6930-4cf0-ac89-fa4e86ef94a8
Category	HUMAN OTC DRUG LABEL
Packager	Raw Health International, LLC
Generic Name
Product Class
Product Number
Application Number	PART348

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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 (Aloe) Leaf Gel, SDA 38B, Glycerin, Mentha Piperita (Peppermint) Oil, Xanthan Gum, Dehydroxyxanthan Gum, Cinnamomum Camphora (Camphor) Bark Oil, Organic Chamomilla Recutita (Matricaria) Flower Extract, 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

ICE

The All-Natural
Cooling Pain Reliever

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

3 fl OZ / 89 mL

www.rawhealthintl.com
Also Try RAW-HEAT for warming pain relief

INGREDIENTS AND APPEARANCE

RAW ICE
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55413-2500
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A)	menthol	34.79 g in 1 L

Ingredient Name	Strength
Inactive Ingredients
aloe vera leaf (UNII: ZY81Z83H0X)
glycerin (UNII: PDC6A3C0OX)
peppermint oil (UNII: AV092KU4JH)
xanthan gum (UNII: TTV12P4NEE)
camphor oil (UNII: 75IZZ8Y727)
matricaria recutita (UNII: G0R4UBI2ZZ)
symphytum uplandicum leaf (UNII: D05HXK6R3G)

#	Item Code	Package Description
Packaging
1	NDC:55413-2500-1	0.089 L in 1 BOTTLE
2	NDC:55413-2500-2	0.118 L in 1 BOTTLE
3	NDC:55413-2500-3	0.004 L in 1 PACKET

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/15/2013

Labeler - Raw Health International, LLC (014982454)

Registrant - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(55413-2500)

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Medic

RAW ICE (MENTHOL) LIQUID [RAW HEALTH INTERNATIONAL, LLC]

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