CVS HEALTH LIDOCAINE PAIN-RELIEVING- lidocaine patch

CVS Health Lidocaine Pain-Relieving by

Drug Labeling and Warnings

CVS Health Lidocaine Pain-Relieving by is a Otc medication manufactured, distributed, or labeled by NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4%

Purpose

Topical Analgesic

Use

For the temporary relief of pain.

Warnings

For external use only

Do not use

• more than one patch at a time
• on wounds or damaged skin
• with a heating pad
• if you are allergic to any ingredients in this product

When using this product

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

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

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/children 12 years and older

• clean and dry affected area
• remove film from patch and apply to the skin (see illustration)
• apply to affected area, not more than 3 to 4 times daily
• remove patch from the skin after, at most, 8-hour application

children 12 years or younger:

• consult a doctor

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, Povidone, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Principal Display Panel – Box Label

CVS
Health

Compare to the active
ingredient in Salonpas®
4% Lidocaine Gel Patch*

MAXIMUM STRENGTH

Lidocaine
Pain-Relieving
Patch

UP TO
8
HOURS

LIDOCAINE 4% GEL

Numbing muscle
& joint relief

For temporary relief of
minor aches & pains:

• Arthritis
• Bruises
• Strains & sprains

Unscented

6 PATCHES

3 15/16” x 5 1/2” (10 cm x 14 cm)

Principal Display Panel – Patch Label

CVS
Health

MAXIMUM STRENGTH

Lidocaine
Pain-Relieving
Patch

LIDOCAINE 4% GEL

Numbing muscle & joint relief

For temporary relief of
minor aches & pains:

• Arthritis
• Bruises
• Strains & sprains

Unscented

1 PATCH

3 15/16” x 5 1/2”

(10 cm x 14 cm)

INGREDIENTS AND APPEARANCE

CVS HEALTH LIDOCAINE PAIN-RELIEVING 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-276
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	567 mg

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POVIDONE K90 (UNII: RDH86HJV5Z)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-276-06	6 in 1 BOX	12/18/2019
1		1 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	12/18/2019

Labeler - Natural Essentials, Inc. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.		529128763	MANUFACTURE(66902-276)