Active Ingredients
Lidocaine HCL 4%
Comfortcaine Gel
FDA Label NDC 65008-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Qs Key West Aloe, Llc for the product Comfortcaine (NDC 65008-005). 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, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients:, other information, 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 pain associated with minor burns, sunburn, scrapes, or minor skin irritations.
Warnings
• For external use only.
• Avoid contact with the eyes.
• Do not use in large quantities, particularly over raw surfaces or blistered areas.
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Keep Out Of Reach Of Children
• If accidentally ingested contact a physician or Poison Control Center immediately.
Directions
• Adults and children 2 years of age or older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: consult a physician.
Inactive Ingredients:
Aloe Barbadensis Leaf Extract, Water, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide, Caprylyl Glycol, Methylisothiazolinone, FD&C Yellow No. 5, FD&C Blue No. 1
Other Information
• Store at room temperature 15-30°C (59-86°F)
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