Perform Pain Relieving Roll-On

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 Essence,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.

----------

Perform Pain Relieving Roll-On

Active Ingredients

Menthol USP 3.1%

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 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: Roll on the 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:

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: 59316-108
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-108-15	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

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

Labeler - Performance Health LLC (794324061)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC		557434805	manufacture(59316-108)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence,LLC		825646862	manufacture(59316-108)

Revised: 2/2016

Document Id: 2bd580d6-39b1-4892-e054-00144ff88e88

Set id: 3d0ec002-15d2-4332-adcb-09e328ed6f5a

Version: 12

Effective Time: 20160215

 

Performance Health LLC