ACtive Ingredient
Capsaicin 0.1%
Toast Screamin Hot Cream
FDA Label NDC 78983-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ideaz, Llc for the product Toast Screamin Hot (NDC 78983-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop using consult a doctor if, keep out of reach of children, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
for the temporary relief of minor aches and pains of
muscles and joints associated with ■ arthritis ■ strains
■ bruises ■ sprains
Warnings
For external use only:
TEST FIRST ON A SMALL AREA OF SKIN TO
DETERMINE SENSITIVITY.
When Using This Product
■ use only as directed
■ do not bandage tightly ■ do not use with a heating pad
■ avoid contact with the eyes and mucus membranes
■ do not apply to wounds, damaged, broken or rritated skin
■ a slight burning sensation may occur upon application but
generally disappears in several days ■ if burning occurs,
discontinue use ■ do not expose the treated area to heat or
direct sunlight ■ do not use if allergic to capsicum or chili peppers.
Stop Using Consult A Doctor If
■ condition worsens
■ symptoms persist for more than 7 days or clear up and occur
again within a few days ■ redness is present ■ irritation develops.
Keep Out Of Reach Of Children
If swallowed, get medical help
or contact a Poison Control Center immediately.
If Pregnant Or Breast-Feeding
ask a healthcare professional before use.
Directions
■ adults and children 18 years of age or older:
apply to affected area not more than 3 to 4 times daily
■ massage into area until thoroughly absorbed
■ WASH HANDS WITH SOAP AND WATER AFTER APPLYING
■ children under 18 years of age: consult a doctor.
Other Information
■ store at room temperature
Inactive Ingredients
Alcohol, Capsicum Annuum (Chili) Seed Oil, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diethanolamine, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Polysorbate 20, Tapioca Starch, Triethanolamine, Water
Questions Or Comments?
1-800-4NO-PAIN
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