Perform Cool and Soothing Pain Relieving Foot

Perform Cool and Soothing Pain Relieving Foot

Drug Labeling and Warnings

Drug Details

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PERFORM COOL AND SOOTHING PAIN RELIEVING FOOT- menthol spray 
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 Foot

Drug Facts

Active Ingredients

Menthol USP 10.4%

Purpose

Cooling Pain Relief

*Uses:

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

Warnings:

For external use only.

Flamable: Keep away from excessive heat and open flame. ​Contents Under Pressure. Do Not Puncture Or Incinerate. Do Not Store At Temperature Above 120 ​0​F.

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 12 years and older: ​Spray on to affected area up to 4 times daily.
  • ​Children under 12 years age: ​ Consult a physician.

Other Information:

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

Inactive Ingredients:

Alcohol Denat., Arnica Montana Flower Extract, Camellia Sinensis Leaf Extract, Camphor, Citrus Aurantifolia (Lime) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Eucalyptus Globulus Leaf Oil, Ilex Paraguariensis Leaf Extract, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Pinus Palustris Oil, Polysorbate-20, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Water.

Questions or Comments?

[email protected]

1-80-755-2584

Product Label

FootSpray

PERFORM COOL AND SOOTHING PAIN RELIEVING FOOT 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59316-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL104 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
LIME OIL (UNII: UZH29XGA8G)  
ORANGE OIL (UNII: AKN3KSD11B)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
NUTMEG OIL (UNII: Z1CLM48948)  
WHITE PINE OIL (UNII: HA5CX6676U)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
THYME OIL (UNII: 2UK410MY6B)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59316-110-201 in 1 CARTON09/14/2015
1118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/14/2015
Labeler - Performance Health, LLC (794324061)

Revised: 10/2019
 
Performance Health, LLC


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