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  5. Label Information: Lidocaine Patch

FDA Label for Lidocaine Patch

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. DOSAGE AND ADMINISTRATION
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. KEEP OUT OF REACH OF CHILDREN AND PETS.
    10. OTHER SAFETY INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS

Lidocaine Patch Product Label

The following document was submitted to the FDA by the labeler of this product Slv Pharmaceuticals Llc Dba Aum Pharmaceuticals. 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.

Purpose



For temporary relief of minor pain.


Dosage And Administration



Directions: Adults and children 12 years of age and over: Clean and dry affected area. Apply immediately upon removal from pouch. Peel off the first liner and apply exposed patch to affected area. Peel off second liner while applying the rest of patch. Remove patch after 24 hours. Discard patch after single use. Do not expose area to heat.

Children under 12 years of age: Consult a physician.


Warnings



For external use only.


Do Not Use



■ if you are allergic to any active or inactive ingredients of this product

■ on wounds or damaged, irretated, or sensitive skin

■ with any other topical anesthetic

■ for more than one week without consulting a doctor

■ with a heating pad

■ if pouch is damaged or open


When Using This Product



■ do not allow contact with the eyes

■ use only as directed, read and follow all directions and warnings on this package

■ do not bandage tightly or apply local heat

■ Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

■ do not reuse patch


Stop Use And Ask A Doctor If



■ symptoms persist for more than seven days or clear up and occur again within a few days

■ condition worsens

■ localized skin reactions occur such as rash, pain, itching, redness, irritation, swelling or blistering.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Keep Out Of Reach Of Children And Pets.



If chewed or swallowed, get medical help or contact a Poison Control Center right away. (800-222-1222)


Other Safety Information



Store in a clean, dry place outside of direct sunlight.  Store in original unopened pouch protected from moisture.


Inactive Ingredients



alicyclic hydrocarbon resin, mineral oil, polyester film, silicon-coated polyester film and styrene isoprene styrene block copolymer.


Questions



Questions? 1-866-760-6565, Monday - Friday 8:30 a.m - 4:30 p.m. EST

Manufactured for:
AUM Pharmaceuticals
Hauppauge, NY 11788


Made in USA From Domestic and Imported Components


* Please review the disclaimer below.