FDA Label for Comfortcaine
View Indications, Usage & Precautions
Comfortcaine Product Label
The following document was submitted to the FDA by the labeler of this product Qs Key West Aloe, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Lidocaine HCL 4%
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)
Questions Or Comments?
1-800-445-2563
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