Dynafreeze (Menthol) Liquid [Performance Health Llc] -

DYNAFREEZE (MENTHOL) LIQUID [PERFORMANCE HEALTH LLC]
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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59316-301-10	118 mL in 1 TUBE; Type 0: Not a Combination Product	08/25/2010	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/25/2010	12/31/2021

Labeler - Performance Health LLC (794324061)

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

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

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

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