Lidocaine by FORREAL PHARMACEUTICALS LLC LIDOCAINE patch

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by FORREAL PHARMACEUTICALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 4%

PURPOSE

Topical Anesthetic

INDICATIONS & USAGE

For the temporary relief of pain

WARNINGS

For external use only

DO NOT USE

Do not use

• More than 1 pathch at a time
• On wounds or damaged skin
• With a heating pad
• If you are allergic to any ingredients of this product

WHEN USING

When using this product

• Use only as directed
• Avoid contact with the eyes, mucous membranes or rashes
• Do not bandage tightly

STOP USE

Stop use and ask a doctor if

• Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• Conditions worsen
• Symptoms persist for more than 7 days
• Symptoms clear up and occur again within a few days

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years of age and over:

• Clean and dry the affected area
• Open pouch and remove one patch
• Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
• Reseal pouch containing unused patches after each use
• Remove patch from the skin after at most 8-hour application ​

​Children under 12 years of age: Consult a doctor

Other information:

• Avoid storing product in direct sunlight
• Protect product from excessive moisture

INACTIVE INGREDIENT

Other ingredients: Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

Questions or comments? 877-367-3250

PRINCIPAL DISPLAY PANEL

Packaged For:

Forreal Pharmaceuticals LLC

Royal Oak, MI 48067

Questions or Comments please call 877-367-3250

NDC: 81877-514-15

Qty:15 Patches

(5 per Resealable Pouch) x 3

Lidocaine 4%

Topical Pain Patch

for temporary pain relief

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81877-514
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
KAOLIN (UNII: 24H4NWX5CO)
SILODRATE ANHYDROUS (UNII: 59110L5W24)
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
UREA (UNII: 8W8T17847W)

Product Characteristics
Color		Score
Shape	RECTANGLE (White Flexible Patch)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81877-514-15	3 in 1 BOX	06/27/2022
1		1 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/27/2022

Labeler - FORREAL PHARMACEUTICALS LLC (118029197)