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  5. Label Information: Sclera Care Topical Anesthetic Gel

FDA Label for Sclera Care Topical Anesthetic Gel

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT:
    2. PURPOSE
    3. USES:
    4. WARNINGS:
    5. WHEN USING THIS PRODUCT
    6. DO NOT USE
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. IF PREGNANT OR BREAST FEEDING,
    10. DIRECTIONS:
    11. INACTIVE INGREDIENTS:
    12. OTHER INFORMATION:
    13. QUESTION?
    14. PACKAGE LABELING:5ML
    15. PACKAGE LABELING:118ML

Sclera Care Topical Anesthetic Gel Product Label

The following document was submitted to the FDA by the labeler of this product Scleracare, Llc. 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.

Active Ingredient:



Lidocaine hydrochloride 3.00%


Purpose



Topical Anesthetic


Uses:



• For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.


Warnings:



• For external use only not intended for ingestion.


When Using This Product



• Avoid contact with eyes


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.


Keep Out Of Reach Of Children.



• If swallowed, get medical help or contact a Poison Control Center right away.
• Do not apply to wounds or damaged skin.
• Do not bandage tightly.


If Pregnant Or Breast Feeding,



• contact a physician prior to use.


Directions:



• Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
• Children under two-years of age: Consult a physician.


Inactive Ingredients:



a-Bisabalol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexylglycerin, Opuntia Vulgaris (Prickly Pear) Extract, Persea gratissima (Avocado) Oil, Phenoxyethanol, Polysorbate-20, Sodium Alginate, Squalane, Triethanolamine.


Other Information:



• Store at room temperature


Question?



337-526-6744 (M-F) (9-5pm CST)


Package Labeling:5Ml



Label - Label

Label - Label


Package Labeling:118Ml



Label2 - Label2

Label2 - Label2


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