GERIGENTLE FROSTYHEAT PAIN RELIEF PATCH 4 LODOCAINE BACK- lidocaine patch

GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back by

Drug Labeling and Warnings

GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back by is a Otc medication manufactured, distributed, or labeled by Geri-Gentle Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

For temporary relief of pain

Warnings:

For external use only

Do not use

• More than 1 patch at a time
• on wounds or damaged skin
• with heating pad
• if you are allergic to any ingredient of this product.

When using this product

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

Stop use and ask a doctor if

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

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children and pets.

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

Directions:

Adults and children over 12 years:

• Clean and dry affected area.
• remove film from patch and apply to skin
• apply 1 patch at a time to affected area, not more than 3 to 4 times daily.
• wear each patch up to 8 hours maximum.
• consult a physcian Children 12 years or younger:

Other information:

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

Inactive ingredients:

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Package Labeling:

INGREDIENTS AND APPEARANCE

GERIGENTLE FROSTYHEAT PAIN RELIEF PATCH 4 LODOCAINE BACK 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69771-010
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 mL

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69771-010-05	4 in 1 POUCH	07/16/2022
1		0.0242 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/16/2022

Labeler - Geri-Gentle Corporation (080367686)