Active Ingredients
Lidocaine 0.5%
Instant Cool Skin
FDA Label NDC 66428-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Therapon Skin Health, Lp for the product Instant Cool Skin (NDC 66428-007). 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 ingredients, uses, indications, warnings, directions, inactive ingredients, package display, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
External Analgesic
Indications
For temporary relief of pain associated with sunburn and minor skin burns.
Warnings
For external use only, avoid contact with eyes. Do not use in large quantities, particularly over raw surfaces or blistered surfaces
Directions
- Adults and children 2 years and older: apply to affected area. Do not use more than 3-4x daily. Repeat daily until healed.
- Children under 2 years of age: consult a doctor
Inactive Ingredients
Water, Ethanol, Propylene Glycol, Lactic Acid
Package Display
Label Back (Label)
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