Otc - Active Ingredient
Menthol 16%
Walgreens Cool And Heat Aerosol, Spray
FDA Label NDC 0363-3031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Walgreens Cool And Heat (NDC 0363-3031). 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, indications & usage, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic
Indications & Usage
Temporarily alleviates minor aches and pains of muscles and joints associated with Arthritis, Simple Backache, Strains, Bruises, or Sprains
Warnings
For external use only.
Flammable: Do not use while smoking or near heat or flames. Avoid long term storage above 104°F. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
Otc - When Using
Avoid contact with eyes and mucous membranes.
Do not apply to wounds or damaged skin. Do not bondage tightly. Use only as directed.
Otc - Ask Doctor
Stop use and ask doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use for longer than 1 week.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).
If pregnant or breast- feeding, ask a health professional before use.
Dosage & Administration
Shake well- adult and children 12 year of age and older: spray product on affected area, not more than 3 to 4 times daily.
Children under 12 years of age: consult a doctor.
Inactive Ingredient
Glycerin, Isobutane, Propylene Glycol, SD Alcohol 40B, Water.
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