PERFORM ATOMIC HEAT- capsaicin, methyl salicylate cream

Perform Atomic Heat by

Drug Labeling and Warnings

Perform Atomic Heat by is a Otc medication manufactured, distributed, or labeled by Performance Health, LLC, Cosmetic Essence, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Capsaicin 0.034%

Methyl Salicylate 10%

Purpose

Topical Analgesic

Uses:

For the temporary relief from minor aches & pains of sore muscles & joints associated with arthritis, backache, strains & sprains.

Warnings:

For external use only. Use only as directed.

Keep out of reach of children.

If accidentally ingested, get medical help or contact a Poison Control Center immediately. This product is intended to & may cause a mild temporary skin irritation.  Discontinue use if excessive skin irritation develops.

When Using This Product:

• Avoid contact with eyes or mucous membranes

• Do not apply to wounds, broken skin or irritated skin
• Do not use with other ointments, creams, sprays, liniments or other NSAIDs
• Do not apply to irritated skin or if excessive irritation develops
• Do not bandage
• Wash hands with soap & cool water after using
• Do not expose treated area to direct sunlight, heat or warm/hot water

Stop Use and Ask a Doctor If:

Condition worsens or if symptoms persist for more than 7 days, or clear up and reoccur

Pregnant or breast-feeding:

 ask a health professional before use

Directions:

Adults/Children 12 years of age and older: Massage into affected area no more than 4 times daily.

• Children under 12 years of age: Consult a physician.
• If first time user, test in a small area.

Other Information:

Store in a cool dry place with lid closed.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanediol, Arnica Montana Flower Extract, Cetearyl Alchohol & Polysorbate 60, Ethylhexylglycerin, Glyceryl Stearate, Ilex Paraguariensis Leaf Extract, Isopentyldiol, O-Cymen-5-Ol, Petrolatum, Polysorbate 80, Vanillyl Butyl Ether, Water

Questions or Comments?

info@performpainrelief.com 1-800-755-2584

Product Label

INGREDIENTS AND APPEARANCE

PERFORM ATOMIC HEAT 
capsaicin, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.34 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-300-30	1 in 1 BOX	06/08/2015	12/31/2023
1		118 mL in 1 TUBE; 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	06/08/2015	12/31/2023

Labeler - Performance Health, LLC (794324061)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		005917047	manufacture(59316-300)