DRUG FACTS

Active Ingredient

Lidocaine 4.0%

Purpose

Topical anesthetic

Use

For temporary relief of pain

WARNINGS

For external use only

Do not use

more than 1 patch at a time
with a heating pad
on wounds or damaged skin
ir you are allergic to any ingredients of this product

When using this product

use only as directed
do not bandage tightly
avoid contact with the eyes, mucous membranes or rashes

Stop use and ask a doctor if

symptoms persist for more than 7 days
conditions worsen
symptoms clear up and occur again within a few days
localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop

If pregnant or breast feeding,

ask a health professional before use

Keep out of reach of children.

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

DIRECTIONS

Adults and children 12 years of age and over:

clean and dry affected area
apply 1 patch at a time to affected area, not more than 3 to 4 times daily
remove film from patch and apply to the skin
Children under 12 years of age: consult a doctor

OTHER INFORMATION

store in a clean, dry place outside of direct sunlight, Protect product from excessive moisture

INACTIVE INGREDIENTS

Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone K90, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

QUESTIONS?

1-888-655-1558

Package Labeling:75568-004-01

Label2

Package Labeling:75568-004-02

Label

CARELAND LIDOCAINE 4 PAIN RELIEVING GEL-PATCHES
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75568-004
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE K90 (UNII: RDH86HJV5Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75568-004-01	1 in 1 BOX	04/06/2023
1		6 in 1 BAG
1		13 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC:75568-004-02	1 in 1 BOX	10/30/2023
2		35 in 1 BAG
2		13 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	04/06/2023

Labeler - Planet (Anhui) Pharmaceutical Co., Ltd. (618456104)

Careland Lidocaine 4% Pain Relieving Gel-Patches