DYNAFREEZE  - menthol liquid 
Performance Health Inc.

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dynaFreeze

Active Ingredient

Menthol      3.5 percent

Purpose

Cooling Pain Relief

Uses:

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, sprains

Warnings: For external use only

Ask a doctor before use if you have: sensitive skin, are pregnant or breast feeding

When using this product:

Avoid contact with eyes or mucous membranes

Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops

Do not bandage or use with heating pad or device, ointments, creams, sprays or liniments

After applying, wash hands with cool water

Stop use and ask a doctor if:

Condition worsens, symptoms persist more than 7 days, or clear up and then recur

Keep out of reach of children

If ingested, get medical help, Contact Poison Control Center immediately

Directions:

Adults / Children 2 years and older: Massage onto affected area up to 4 times daily

Children under 2 years of age: Consult physician

Other Information: Store in a cool dry place, lid closed tightly. Keep away from excessive heat or open flame.

Inactive Ingredients: water, isopropyl alcohol, yerba mate extract, menthol, carbomer, triethanolamine, silicon dioxide, methylparaben, glycerine, propylene glycoil, FD and C blue  1

Questions or Comments 1-800-246-3733

Foot Smart

Pain Relieving Formula

dynaFreeze

Penetrating, Lasting Pain Relief From:

Arthritis Pain

Sore Muscles and Joints

Backache

Greaseless Stainless Vanishing Scent

4 fl oz / 118 mL

DYNAFREEZE  menthol   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 59316-301 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 3.5 mL  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   ISOPROPYL ALCOHOL   ILEX PARAGUARIENSIS LEAF   CARBOMER HOMOPOLYMER TYPE A   TROLAMINE   SILICON DIOXIDE   METHYLPARABEN   GLYCERIN   PROPYLENE GLYCOL   FD&C BLUE NO. 1

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 59316-301-10 118 mL In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/25/2010

Labeler - Performance Health Inc. (794324061)

Establishment
Name	Address	ID/FEI	Operations
Span Packaging		557434805	manufacture

Establishment
Name	Address	ID/FEI	Operations
Cosmetic Essence,LLC		825646862	manufacture

Revised: 11/2010Performance Health Inc.