Zcaine Fast Acting Anesthetic Gel
FDA Label NDC 27789-911
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Phi, Inc for the product Zcaine Fast Acting Anesthetic (NDC 27789-911). 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 zcaine fast acting anesthetic gel, drug facts, active ingredients, purpose, uses:, warnings:, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Drug Facts
Active Ingredients
Lidocaine 4%
Purpose
Topical Anesthetic
Uses:
For the temporary relief of discomfort and pain associated with
- minor burns and skin irritations
- minor cuts and scrapes
- itching
Warnings:
For external use only.
Avoid contact with eyes.
Do not use In large quantities, particularly over raw surfaces or blistered areas
Stop use and ask a doctor if
- skin becomes irritated
- condition worsens or symptoms last more than 7 days
- symptoms clear up and reoccur within a few days
Keep Out Of Reach Of Children
Directions
Adults and children 12 years of age or older: Apply to affected area not more than 3 to 4 times daily.
Other Ingredients:
Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia
Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria)
Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol,
Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2,
Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine
Zcaine Fast Acting Anesthetic Gel 2Oz/60G
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