Otc - Active Ingredient
Active Ingredient Purpose
Methyl salicylate 31% topical analgesic
Menthol 11% topical analgesic
Freezin Cold Toast
FDA Label NDC 52099-8000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Q.a. Laboratories for the product Freezin Cold Toast (NDC 52099-8000). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
USES temporarily relieves minor body aches and pains of muscle and joints associated with: simple backache
arthritis sprains bruises strains
Warnings
Warnings for external use only
Otc - Do Not Use
Do not use ¡ on wounds ¡ on damaged skin
¡ with a heating pad ¡ on a child under 12
years of age with arthritis-like conditions
Otc - Ask Doctor
Ask a doctor before use if you have
redness over the affected area.
Otc - When Using
When using this product ¡ avoid contact
with eyes and mucous membranes ¡ do
not bandage tightly
Otc - Stop Use
Stop use and ask doctor if ■ condition
worsens or symptoms persist for more than
7 days ■ symptoms clear up and occur within
a few days ■ excessive skin irritation occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of accidental ingestion, get medical
help or contact a Poison Control Center right
away (1-800-222-1222)
Indications & Usage
Directions ¡ use only as directed
¡ adults and children 12 years of age
or older: apply to af fected area not more
than 3 to 4 times daily ¡ children under
12 years of age: ask a doctor
Safe Handling Warning
Other information
■ store between 20-25° C (68-77°F).
■ Protect from freezing
Inactive Ingredient
Inactive ingredients
DEIONIZED WATER, CETEARYL ALCOHOL,
ISOPROPYL MYRISTATE, ISOCETYL STEARATE,
POLYSORBATE 60, SODIUM POLYACRYLOYLDIMETHYL
TAURATE, PHENOXYETHANOL,
HYDROGENATED POLYDECENE, CHAMOMILLA
RECUTITA (MATRICARIA) FLOWER EXTRACT,
METHYL PARABEN, TRIDECETH-10,
ROSMARINUS OFFICINALIS (ROSEMARY),
LEAF EXTRACT, FRANKINCENSE EXTRACT,
PROPYL PARABEN
Otc - Questions
Questions or comments:
1-800-4NO-PAIN,
toastproducts.com
MFD FOR: Toast Products
400 Sproul Street,
Pittsburgh, PA 15136
MFG IN USA
Dosage & Administration
apply to affected area not more
than 3 to 4 times daily
* Please review the disclaimer below.
