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Perform Atomic Heat by Performance Health, LLC

Medically reviewed on July 28, 2016

Dosage form: cream
Ingredients: CAPSAICIN 0.3mg in 1mL, METHYL SALICYLATE 100mg in 1mL
Labeler: Performance Health, LLC
NDC Code: 59316-304

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 Atomic Heat

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:

PERFORM ATOMIC HEAT 
capsaicin, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-304
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.3 mg  in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
AMINOMETHYL PROPANEDIOL 
CETOSTEARYL ALCOHOL 
POLYSORBATE 60 
ETHYLHEXYLGLYCERIN 
GLYCERYL MONOSTEARATE 
ILEX PARAGUARIENSIS LEAF 
ISOPENTYLDIOL 
PETROLATUM 
POLYSORBATE 80 
VANILLYL BUTYL ETHER 
WATER 
Packaging
#Item CodePackage Description
1NDC:59316-304-30118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/28/2016
Labeler - Performance Health, LLC (794324061)

 
Performance Health, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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