DYNAFREEZE- menthol liquid 
Performance Health LLC

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.

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dynaFreeze

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:

DynaFreeze

DYNAFREEZE 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-301-10118 mL in 1 TUBE; Type 0: Not a Combination Product08/25/201012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/25/201012/31/2021
Labeler - Performance Health LLC (794324061)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services LLC117101131manufacture(59316-301)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging557434805manufacture(59316-301)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Essence,LLC825646862manufacture(59316-301)

Revised: 3/2021
Document Id: bd2d8203-0182-2bf2-e053-2a95a90a2d9e
Set id: dbdadcb5-89e0-4c2f-86f6-fd149b0c1cf0
Version: 7
Effective Time: 20210310
 
Performance Health LLC