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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Capsaicin 0.03%

Methyl Salicylate 10%

Purpose

Topical Analgesic

Uses:

For the temporary relief form 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 muccus 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 trated area to direct sunlight, hear 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 reccur 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

Package Labeling:

INGREDIENTS AND APPEARANCE

PERFORM ATOMIC HEAT 
capsaicin, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-304
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.3 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
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: 59316-304-30	118 mL in 1 TUBE; Type 0: Not a Combination Product	07/28/2016	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/28/2016	12/31/2023

Labeler - Performance Health, LLC (794324061)