FDA Label for Pain Relief Patch 4% Lidocaine

Otc - Active Ingredient

Lidocaine 4%

Otc - Purpose

Topical Anesthetic

Use

Use Temporarily Relieves Minor Pain

Warnings

For external use only

Otc - Do Not Use

• More than one patch on your body at a time
• On cut, irritated swollen skin
• On puncture wounds
• For more than one week without consulting a doctor
• At the same time as other topical analgesics

When Using This Product

• Use only as directed.
• Read and follow all directions and warnings on this label.
• Rare case of serious burns have been reported with products of this type.
• Do not apply to wounds or damaged, broken or irritated skin.
• Do not allow contact with the eyes and mucous membranes.
• Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
• Do not use at the same time as other topical analgesic.
• 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
• A transient burning sensation may occur upon application but generally disappears in several days.
• If a severe burning sensation occurs, discontinue use immediately.
• Discontinue use at least 1 hour before a bath or shower.
• Do not use immediately after a bath or shower.

Stop Use And Ask Doctor If

• 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 breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adult and children over 12 years

• Clean and dry affected area.
• Remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle.
• Carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area.
• Use 1 patch for up to 12 hours.

Children 12 years or younger:

• ask a doctor

Other Information:

Store in a clean dry place outside of direct sunlight protect from excessive moisture.

Inactive Ingredient

Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Butylated Hydroxytoluene, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polysorbate, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide.

Package Label.Principal Display Panel

NDC 69618-082-35

Pain Relief Patch

4% Lidocaine

Topical Anesthetic/ Analgesic

Temporary Pain Relief

Back & Neck

Shoulders

Knee & Elbow

*compare to active ingredient in Aspercream Patches

Fast Acting 12/HR Max Strength

6 patches: 10cm X 14CM, individually packaged

Questions? Call 516-341-0666 Mon-Fri 9am-5pm

Distributed by

Reliable 1 Laboratories LLC

99 W. Hawthorne Ave, Suite 610

Valley Stream, NY 11580