Lidostat Cream
FDA Label NDC 44577-704
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clinical Therapeutic Solutions for the product Lidostat (NDC 44577-704). 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 lidostat cream, active ingredient, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Lidocaine HCL 4%
Purpose
External Anesthetic
Uses:
For temporary relief of pain and itching caused by minor skin irritations.
Warnings:
For external use only.
Do Not Use
on children under 2 years of age unless directed by a physician.
When Using This Product
avoid contact with eyes Use only as directed. Do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop Use And Ask A Doctor If:
- symptoms persist for more than seven days, or clear up and occur again within a few days.
- redness, irritation, swelling, pain or other symptoms increase
Keep Out Of Reach Of Children.
If swallowed, consult a physician.
Directions:
For adults and children two-years or older, apply externally to the affected area. Do not use more than three to four times per day.
Children under 2 years of age: Ask a doctor.
Other Information:
Store at room temperature (68-77°F) (20°-25°C)
Other Ingredients:
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bin Vinyl Dimethicone/Dimethicone Copolymer, C13-14 Isoparaffin, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Laureth-7, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Stearic Acid, Triethanolamine, Urea.
Question Or Comments?
Please visit www.BakoCTS.com
Lidostattm Cream
Distributed by:
CLINICAL THERAPEUTIC SOLUTIONS
A Part of bako's Integrated Physician Solution
PO Box 1257, Wall, NJ 07719
732.894.9450 •
www.BakoCTS.com
Package Label.Principal Display Panel
LidoStat CREAM
Lidocaine HCI 4%
In a 20% Urea Vehicle
MEDICAL STRENGTH PAIN CREAM
PENETRATING FORMULA
Dipensed Only by Physicians
NET WT. 2.0 oz (56 g)
LOT:
EXP:
Lidostat Cream 2Oz/56G (44577-704-02)
Inner Label (Innerlabel)
Outer Label (Outerlabel)
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