CVS HEALTH XL LIDOCAINE PAIN RELIEF- lidocaine patch

CVS Health XL Lidocaine Pain Relief by

Drug Labeling and Warnings

CVS Health XL Lidocaine Pain Relief 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 Anesthetic

Use

For the temporary relief of pain.

Warnings

For external use only

Do not use

• more than 1 patch on your body at a time or on cut, irritated or swollen skin
• on puncture wounds
• for more than one week without consulting a doctor

When using this product

• use only as directed. Read and follow all directions and warnings on this carton.
• do not allow contact with the eyes or mucous membranes
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
• do not use at the same time as other topical analgesics
• dispose of used patch in manner that always keeps product away from children and 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 and ask a doctor if

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

If pregnant or breast-feeding, ask a physician 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 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
• once applied, press firmly and rub on all sides and center of patch to help adhesive adhere to skin
• do not remove patch and reapply, this will result in patch not sticking
• avoid strenuous exercise while wearing patch, this will result in patch not sticking.
• use 1 patch for up to 12 hours

Children 12 years or younger: ask a doctor

Other information

Store at room temperature - do not exceed 86° Fahrenheit, 30° Celsius.

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
Aspercreme® Lidocaine Patch XL*

MAXIMUM STRENGTH

Lidocaine Pain
Relief Patch

XL

LIDOCAINE 4%

Topical anesthetic

Odor Free

• Desensitizes
  aggravated nerves
• Fast acting
• Easy to apply
• No irritation
  or burning

UP TO
12
HOURS

3 PATCHES Individually wrapped

4 3/4” x 7 7/8” (12 cm x 20 cm)

Pain relieving ointment on a breathable adhesive pad

Principal Display Panel – Patch Label

CVS
Health

Compare to the active ingredient in
Aspercreme® Lidocaine Patch XL*

MAXIMUM STRENGTH

Lidocaine Pain
Relief Patch

XL

LIDOCAINE 4%

Topical anesthetic

Odor Free

• Desensitizes
  aggravated nerves
• Fast acting
• Easy to apply
• No irritation
  or burning

UP TO
12
HOURS

1 PATCH

4 3/4” x 7 7/8” (12 cm x 20 cm)

Pain relieving ointment on a breathable adhesive pad

INGREDIENTS AND APPEARANCE

CVS HEALTH XL LIDOCAINE PAIN RELIEF 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-286
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	858 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: 66902-286-03	3 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(66902-286)