Active Ingredient(S)
Lidocaine 2.00% w/w — External Analgesic
Calexotics Anal Eze Gel
FDA Label NDC 88055-113
9 label sections · Submitted to the FDA by California Exotic Novelties Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by California Exotic Novelties Llc for the product Calexotics Anal Eze (NDC 88055-113). 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(s), purpose, use, warnings, directions, otc - keep out of reach of children, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Use
For Temporary Relief of Pain.
Warnings
For External Use Only. 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 physician. Keep out of reach of children. Avoid contact with the eyes.
Directions
Apply to affected area no more than 3 to 4 times daily.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Other Information
Store at 20–25° C (68–77° F)
Inactive Ingredients
Behenyl Betaine, Cocamidopropylamine Oxide, Dimethicone, Disiloxane, Glycerin, PEG-20 Almond Glycerides, Silica
Package Label - Principal Display Panel
Label (Labele)
42 G
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