PAIN RELIEF LIDOCAINE- lidocaine patch

PAIN RELIEF LIDOCAINE by

Drug Labeling and Warnings

PAIN RELIEF LIDOCAINE by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredientPurpose
Lidocaine 4%.................................................... Topical anesthetic

PURPOSE

Use
■ temporarily relieves minor pain

WARNINGS

For external use only

DO NOT USE

Do not use
■ more than 1 patch on your body at a time or on cut, irritated or
swollen skin ■ at the same time as other topical analgesics
■ on puncture wounds
■ for more than one week without consulting a doctor

WHEN USING

When using this product
■ use only as directed. Read and follow all directions and
warnings on this label. ■ do not allow contact with the eyes
■ do not bandage tightly or apply local heat (such as heating
pads) to the area of use
■ discontinue use at least 1 hour before a bath or shower
■ do not use immediately after a bath or shower
■ dispose of used patch in manner that always keeps product
away from children or 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

Stop use and ask a doctor if
■ condition worsens ■ redness is present
■ symptoms persist for more than 7 days or clear up and occur
again within a few days ■ irritation develops
■ you experience signs of skin injury, such as pain, swelling, or
blistering where the product was applied

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 (1-800-222-1222) right away.

INDICATIONS & USAGE

Directions
■ adults and children over 12 years:
■ clean and dry affected area
■ remove backing from patch by firmly grasping both ends and
gently pulling until backing separates in middle
■ carefully remove smaller portion of backing from patch and
apply exposed portion of patch to affected area
■ once exposed portion of patch is positioned, carefully
remove remaining backing to completely apply patch to
affected area ■ use 1 patch for up to 12 hours
■ children 12 years or younger: ask a doctor

STORAGE AND HANDLING

Other information
■ store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients alcohol, aluminum glycinate, glycerin,
kaolin, methylparaben, polysorbate 80, propylparaben, purified
water, sodium polyacrylate, tartaric acid, titanium dioxide

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320 USA

MADE IN CHINA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF LIDOCAINE 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-959
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
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALCOHOL (UNII: 3K9958V90M)
KAOLIN (UNII: 24H4NWX5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-959-01	1 in 1 POUCH	09/07/2018
1		0.04 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/07/2018

Labeler - FAMILY DOLLAR (024472631)