FDA Label for Zylotrol
View Indications, Usage & Precautions
- 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
- OTC - PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Zylotrol Product Label
The following document was submitted to the FDA by the labeler of this product Asclemed Usa, Inc.. 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.
Otc - Active Ingredient
Active Ingredients
Lidocaine HCl 4%
Menthol 1%
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
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