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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. IDICATIONS AND USAGE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND CONSULT A DOCTOR
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. DO NOT USE
    10. KEEP OUT OF REACH OF CHILDREN AND PETS.
    11. OTHER SAFETY INFORMATION
    12. INACTIVE INGREDIENTS
    13. 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



Temporarily relieves minor pain.


Dosage And Administration



Directions Adults and children over 12 years:

■ clean and dry affected area

■ carefully remove backing from patch starting at corner

■ apply sticky side of patch to affected area

■ use one patch for up to 24 hours. Discard patch after single use. Children under 12 years of age: consult a physician.


Warnings



For external use only.


Idications And Usage



Uses: Temporaily relieves minor pains.


When Using This Product



■ use only as directed

■ read and follow all directions and warnings on this carton

■ do not allow contact with the eyes

■ do not use at the same time as other topical analgesics

■ do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ do not microwave

■ dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.


Stop Use And Consult A Doctor



■ condition worsens

■ redness is present

■ irritation develops

■ symptoms persist for more than 7 days or clear up and occur again within a few days

■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.


Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, ask a health professional before use.


Do Not Use



■ more than one patch on your body at a time

■ on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

■ if you are allergic to any active or inactive ingredients

■ if pouch is damaged or opened.


Keep Out Of Reach Of Children And Pets.



If 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. Protect from excessive moisture.


Inactive Ingredients



Styrene Isoprene Styrene block Copolymer, Alicyclic Saturated Hydrocarbon Resin, White Mineral Oil


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


* Please review the disclaimer below.