PERFORM COOL and SOOTHING PAIN RELIEVING

PERFORM COOL and SOOTHING PAIN RELIEVING

Drug Labeling and Warnings

Drug Details

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PERFORM COOL AND SOOTHING PAIN RELIEVING- menthol gel 
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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PERFORM COOL and SOOTHING PAIN RELIEVING

Drug Facts

Active Ingredients

Menthol 3.5%

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 and 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 a heating pad or device, ointments, creams, sprays, liniments
  • Wash hands with cool water after using

Stop Use and Ask 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/Children 2 years or older:  Massage onto 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 close tightly.

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Blue 1, Camelia Sinensis Leaf Extract, Carbomer, Citrus Aurantifolia (lime) Oil, Citrus Auratium Dulcis (Orange) Peel Oil, Eucalyptus Globulus Leaf Oil, Glycerin, Hypericum Perforatum Oil, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Lavandula Hybrida Oil, Mentha Piperita (Peppermint) Oil, Myristica Fragrans (Nutmeg) Kerneol Oil, Pinus Sytvestris Leaf Oil, Polysorbate 20, Silica, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Triethanolamine, Water.

Questions or Comments?

[email protected]   1-800-755-2584

Product Label

Carton

PERFORM COOL AND SOOTHING PAIN RELIEVING 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59316-111
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
LIME OIL (UNII: UZH29XGA8G)  
ORANGE OIL (UNII: AKN3KSD11B)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPERICUM OIL (UNII: OZU2FC70HY)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LAVANDIN OIL (UNII: 9RES347CKG)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
NUTMEG OIL (UNII: Z1CLM48948)  
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
THYME OIL (UNII: 2UK410MY6B)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59316-111-201 in 1 CARTON05/18/2015
1118 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 59316-111-103 mL in 1 TUBE; Type 0: Not a Combination Product05/18/2015
3NDC: 59316-111-1130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/18/2015
Labeler - Performance Health, LLC (794324061)

Revised: 9/2019
 
Performance Health, LLC


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