Otc - Active Ingredient
Active Ingredients
Lidocaine HCl 4%
Menthol 1%
Zylotrol Gel
FDA Label NDC 76420-145
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Asclemed Usa, Inc. for the product Zylotrol (NDC 76420-145). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Topical Analgesic
Indications & Usage
Uses
For the temporary relief of pain.
Warnings
Warnings
For external use only not intended for ingestion.
Otc - Do Not Use
Do not use
- in large quantities, particularly over raw surfaces, or blistered areas.
Otc - When Using
When using this product
- Avoid contact with the eyes.
Otc - Ask Doctor
Stop use and ask a doctor if
- condition worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help, or contact a Poison Control Central right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
Directions
- Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times a daily.
- Children under 2 years of age: consult a doctor.
Other Safety Information
Other information
- Store at 20-25 oC (68-77 oF) and protect from moisture.
Inactive Ingredient
Inactive ingredients
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Isopropyl Alcohol, Phenoxyethanol, Triethanolamine.
Otc - Questions
Questions?
(310) 320-0100
Other
Relabeled by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501
Package Label.Principal Display Panel
Label (Zylotrol)
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