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  5. Label Information: Lidostat

FDA Label for Lidostat

View Indications, Usage & Precautions

Table of Contents

    1. LIDOSTAT CREAM
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES:
    5. WARNINGS:
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF:
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS:
    11. OTHER INFORMATION:
    12. OTHER INGREDIENTS:
    13. QUESTION OR COMMENTS?
    14. LIDOSTATTM CREAM
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    16. LIDOSTAT CREAM 2OZ/56G (44577-704-02)

Lidostat Product Label

The following document was submitted to the FDA by the labeler of this product Clinical Therapeutic Solutions. 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.

Lidostat Cream





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

Inner Label - InnerLabel


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