GOODSENSE PAIN RELIEF- lidocaine patch

GoodSense Pain Relief by

Drug Labeling and Warnings

GoodSense Pain Relief by is a Otc medication manufactured, distributed, or labeled by Geiss, Destin & Dunn, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Lidocaine 4%..................................................................Topical anesthetic.

PURPOSE

Use

• temporarily relieves minor pain

WARNINGS

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 matter 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 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:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOODSENSE PAIN RELIEF 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-838
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALCOHOL (UNII: 3K9958V90M)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-838-05	5 in 1 CARTON	02/21/2019
1		1 in 1 POUCH; 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	02/21/2019

Labeler - Geiss, Destin & Dunn, Inc (076059836)