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

Active Ingredients

Menthol USP   10.4% 

Purpose

Cooling Pain Relief

Uses:

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

Warnings:

For external use only.

Flammable:

Keep away from excessive heat or open flame.

Ask a Doctor Before Using This Product 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

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:

Other Information:

Store in a cool, dry place out of direct sunlight.

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

Representative Labeling

59316-109-27

PERFORM 
menthol spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-109
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 104 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ARNICA MONTANA (UNII: O80TY208ZW)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
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)  
THYME OIL (UNII: 2UK410MY6B)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59316-109-27 10 in 1 BOX
1 1 mL in 1 PATCH
2 NDC:59316-109-29 118 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 01/10/2013
Labeler - Performance Health LLC (794324061)
Establishment
Name Address ID/FEI Business Operations
Span Packaging Services LLC 557434805 manufacture(59316-109)
Establishment
Name Address ID/FEI Business Operations
Tapemark Company 006154595 manufacture(59316-109)

Revised: 2/2014
Document Id: 987d0396-185c-40a0-a234-afdced00e0ec
Set id: e0ffb170-314c-4476-ac34-35a8931282bb
Version: 2
Effective Time: 20140213
 
Performance Health LLC