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Perform by Performance Health LLC

Medically reviewed on February 15, 2018

Dosage form: gel
Ingredients: MENTHOL 31mg in 1mL
Labeler: Performance Health LLC
NDC Code: 59316-108

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.

Perform Pain Relieving Roll-On

Active Ingredients

Menthol USP 3.1%

Purpose

Cooling Pain Relief

Uses:

Soothing temporary relief from minor aches and pains associated with sore muscles, strains, joint discomfort and arthritis.

Warnings:

For external use only

Flammable: Keep away from excessive heat or open flame

Ask a Doctor Before Using if You:

Have sensitive skin, are pregnant or are breastfeeding

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, liniments
  • Wash hands with cool water after using

Stop Use and Ask a Doctor If:

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

Keep Out of Reach of Children:

If ingested, get medical help Contact Poison Control Center immediately

Directions:
  • Adults and Children 2 years and older: Roll on the affected area up to 4 times daily
  • Children under 2 years of age: Consult a physician


Other Information:

Store in a cool, dry place, with lid closed tightly.

Inactive Ingredients:

Carbomer, FD and C Blue 1, Glycerine USP, Ilex Paraguariensis Extract, Isopropyl Alcohol USP, Propylene Glycol USP, Methyl Paraben, Purified Water, Silicon Dioxide, Triethanolamine

Questions or Comments?

1-800-755-2584

Representative Labeling
PERFORM 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-108
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL31 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GLYCERIN 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL ALCOHOL 
PROPYLENE GLYCOL 
METHYLPARABEN 
WATER 
SILICON DIOXIDE 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:59316-108-1589 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/30/200912/31/2019
Labeler - Performance Health LLC (794324061)
Establishment
NameAddressID/FEIOperations
Span Packaging Services LLC557434805manufacture(59316-108)
Establishment
NameAddressID/FEIOperations
Cosmetic Essence,LLC825646862manufacture(59316-108)

 
Performance Health LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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