Cool And Heat
FDA Label NDC 36800-730

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Top Care for the product Cool And Heat (NDC 36800-730). 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, flammable, when using this product, stop use and ask a doctor if, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                          Purpose

Menthol 16%                                 Topical analgesic

Uses

• temporarily relief of pain and itching associated with:

• arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains

Flammable

• do not use while smoking or near heat or flame
• avoid long term storage above 104​oF
• do not puncture or incinerate. Contents under pressure
• do not store at temperature above 120​oF

When Using This Product

• avoid contact with eyes and mucous membranes
• do not apply to wounds or damages skin
• do not bandage tightly
• use only as directed

Stop Use And Ask A Doctor If

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
•needed for longer than 1 week

Directions

• shake well
• adults and children 12 years of age and older: spray on affected area, not more than 3 to 4 times daily
• children under 12 years of age: consult a doctor

Inactive Ingredients

Glycerin, Propylene Glycol, SD Alcohol 40, Water

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