Perform Pain Relieving Spray

Perform by

Drug Labeling and Warnings

Perform by is a Otc medication manufactured, distributed, or labeled by Performance Health LLC, Span Packaging Services LLC, Cosmetic Essense, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PERFORM- 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 Pain Relieving Spray

Active Ingredients

Natural Menthol USP 10%

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 a 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: Spray on to 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:

Arnica Extract, Eucalyptus Oil, Ilex Paraguariensis Extract, Lavender Oil, Lime Oil, Natural Camphor USP, Nutmeg Oil, Orange Oil, Peppermint Oil, Pine Oil, Polysorbate 20, SD Alcohol 39 C, Thyme Oil, Purified Water, White Tea Extract

Questions or Comments?

1-800-755-2584

COOLING MENTHOL FORMULA GREASELESS  PERFORM PAIN RELIEVING SPRAY  SOOTHING RELIEF FOR ARTHRITIS, SORE MUSCLES, AND JOINT DISCOMFORT   FROM THE MAKERS OF BIOFREEZE   4 fl oz / 118 mL

4 fl oz 118ml

FROM THE MAKERS OF BIOFREEZE

COOLING MENTHOL FORMULA GREASELESS
PERFORM
PAIN RELIEVING SPRAY
SOOTHING RELIEF FOR ARTHRITIS, SORE MUSCLES, AND JOINT DISCOMFORT

Distributed By
Performance Health LLC
Akron, OH 44310
perform phi.us
PUSATQ4 BO1 REV1 09

Product Label

PERFORM 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA (UNII: O80TY208ZW)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
LIME OIL (UNII: UZH29XGA8G)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
NUTMEG OIL (UNII: Z1CLM48948)
ORANGE OIL (UNII: AKN3KSD11B)
PEPPERMINT OIL (UNII: AV092KU4JH)
WHITE PINE OIL (UNII: HA5CX6676U)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALCOHOL (UNII: 3K9958V90M)
THYME OIL (UNII: 2UK410MY6B)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-107-25	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/30/2009	12/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/30/2009	12/31/2016

Labeler - Performance Health LLC (794324061)

Revised: 1/2020

Document Id: 9d60155b-96ee-0641-e053-2995a90ac135

34390-5

Set id: 3a78d477-ea3c-4215-8a36-c11720132706

Version: 16

Effective Time: 20200130

 

Performance Health LLC