Perform Pain Relieving Gel

Perform by

Drug Labeling and Warnings

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

Drug Details [pdf]

PERFORM- 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 Pain Relieving Gel

Drug Facts

Active Ingredient

Menthol USP 3.1%

Purpose

Cooling Pain Relief

Uses:

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

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:

Keep Out of Reach of Children:

If ingested, get medical help. Contact Poison Control Center immediately.

Directions:

  • Adults and Children 2 years and older: Massage onto affected area up to 4 times daily
  • Children under 2 years of age:  Consult physician

Other Information:

Store in a cool, dry place

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

59316-106-20
PERFORM 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59316-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL31 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59316-106-105 mL in 1 PACKET; Type 0: Not a Combination Product12/30/200912/31/2019
2NDC: 59316-106-20118 mL in 1 TUBE; Type 0: Not a Combination Product12/30/200912/31/2018
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/FEIBusiness Operations
Span Packaging Services LLC557434805manufacture(59316-106)

Revised: 10/2019
 
Performance Health LLC