PERFORM by Performance Health LLC / Tapemark Company / Span Packaging Services LLC PERFORM- menthol spray

PERFORM by

Drug Labeling and Warnings

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

Drug Details [pdf]

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:

• Adults / Children 12 years and older:  Apply on to affected area up to 4 times daily
• Children under 12 years of age:  Consult a physician

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

INGREDIENTS AND APPEARANCE

PERFORM 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-109
Route of Administration	TOPICAL

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	01/10/2013	12/31/2018
1		1 mL in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 59316-109-29	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/10/2013	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/10/2013	12/31/2023

Labeler - Performance Health LLC (794324061)

Establishment
Name	Address	ID/FEI	Business Operations
Tapemark Company		006154595	manufacture(59316-109)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC		117101131	manufacture(59316-109)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC		557434805	manufacture(59316-109)