DYNAFREEZE- menthol liquid

dynaFreeze by

Drug Labeling and Warnings

dynaFreeze by is a Otc medication manufactured, distributed, or labeled by Performance Health LLC, Span Packaging Services LLC, Span Packaging, Cosmetic Essence,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Menthol 3.5%

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 glycol, FD and C blue 1

Questions or Comments?

1-800-246-3733

Package Labeling:

INGREDIENTS AND APPEARANCE

DYNAFREEZE  
menthol liquid

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
TROLAMINE (UNII: 9O3K93S3TK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-301-10	118 mL in 1 TUBE; Type 0: Not a Combination Product	08/25/2010

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 LLC (794324061)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC		117101131	manufacture(59316-301)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging		557434805	manufacture(59316-301)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence,LLC		825646862	manufacture(59316-301)