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dynaFreeze

Medically reviewed on Dec 19, 2017

Dosage form: liquid
Ingredients: MENTHOL 35mg in 1mL
Labeler: Performance Health LLC
NDC Code: 59316-301

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

dynaFreeze

dynaFreeze

Active IngredientMenthol 3.5%

PurposeCooling 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

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  Distributed by Performance Health, LLC  Akron, OH 44310   Made in the USA   No Animal Testing

Product Label

DYNAFREEZE  
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-301
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ALCOHOL 
ILEX PARAGUARIENSIS LEAF 
TROLAMINE 
SILICON DIOXIDE 
METHYLPARABEN 
GLYCERIN 
PROPYLENE GLYCOL 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:59316-301-10118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/25/2010
Labeler - Performance Health LLC (794324061)
Establishment
NameAddressID/FEIOperations
Span Packaging557434805manufacture(59316-301)
Establishment
NameAddressID/FEIOperations
Cosmetic Essence,LLC825646862manufacture(59316-301)

 
Performance Health LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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