PERFORM ATOMIC HEAT- capsaicin, methyl salicylate cream 
RB Health (US) 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.

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PERFORM ATOMIC HEAT

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 immedicately.

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 membrances

  • Do not apply to sounds, broken skin or irritated skin
  • Do not use with other ointments, creams, sprays, liniments or orther NSAIDs
  • Do no apply to irritated skin or if excessive irritation develops
  • Do not bandage
  • Wash hads 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 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 Alcohol & Polysorbate 60, Ehtylhexylglycerin; Glyceryl Stearate; Ilex Paraguariensis Leaf Extract, Isopentyldiol, O-Cymen-5-ol, Petrolatum, Polysorbate 80, Vanillyl Butyl Ether, Water

Questions or Comments?

info@performapainrelief.com 1800-755-2584

Package Label

image description

PERFORM ATOMIC HEAT 
capsaicin, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.34 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-302-1089 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/201504/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/06/201504/30/2018
Labeler - RB Health (US) LLC (081049410)

Revised: 7/2023
Document Id: 01cd01a8-1dff-d251-e063-6294a90ab5d2
Set id: 0e3cb1ba-4bd1-4e63-beae-954d11edeae3
Version: 4
Effective Time: 20230731
 
RB Health (US) LLC