PERFORM ATOMIC HEAT- capsaicin, methyl salicylate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

Performance Health, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

PERFORM ATOMIC HEAT- CAPSAICIN, METHYL SALICYLATE CREAM
PERFORMANCE HEALTH, 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
_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 Buty