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

PERFORM
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59316-106
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	31 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59316-106-10	5 mL in 1 PACKET; Type 0: Not a Combination Product	12/30/2009	12/31/2019
2	NDC:59316-106-20	118 mL in 1 TUBE; Type 0: Not a Combination Product	12/30/2009	12/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/30/2009	12/31/2019

Labeler - Performance Health LLC (794324061)

Name	Address	ID/FEI	Business Operations
Establishment
Span Packaging Services LLC		557434805	manufacture(59316-106)

Revised: 10/2019

Document Id: 95fb0673-a5b4-2fdc-e053-2995a90a9f76

Set id: c7ab3bc6-52a5-4d23-9c72-53e92b6859f0

Version: 20

Effective Time: 20191028

Performance Health LLC