CVS HEALTH LIDOCAINE PAIN RELIEF PLUS MENTHOL- lidocaine, menthol, unspecified form patch
NATURAL ESSENTIALS, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Lidocaine 4%

Menthol 1%

Purpose

Topical Anesthetic

Topical Analgesic

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.
Rare cases of serious burns have been reported with products of this type
Do not apply to wounds or damaged, broken or irritated skin
Do not allow contact with the eyes and 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 products 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 completely to 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 the 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 ingredients
in IcyHot® Lidocaine Patch
Plus Menthol*

MAXIMUM STRENGTH

Lidocaine
Pain-Relief
Patch

PLUS MENTHOL

LIDOCAINE HCI 4%

MENTHOL 1%

UP TO
12
HOURS

Desensitizes
aggravated nerves
Easy to apply
Fast acting

Topical Anesthetic

Topical Analgesic

Package Contains 5 Individually
Wrapped Patches

5 PATCHES

3 15/16” x 5 1/2” (10 cm x 14 cm)

Principal Display Panel – Patch Label

CVS
Health

Compare to the active ingredients
in IcyHot® Lidocaine Patch
Plus Menthol*

MAXIMUM STRENGTH

Lidocaine
Pain-Relief
Patch

PLUS MENTHOL

LIDOCAINE HCI 4%

MENTHOL 1%

Desensitizes
aggravated nerves
Easy to apply
Fast acting

Topical Anesthetic

Topical Analgesic

1 PATCH

3 15/16” x 5 1/2” (10 cm x 14 cm)

CVS HEALTH LIDOCAINE PAIN RELIEF PLUS MENTHOL
lidocaine, menthol, unspecified form patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66902-220
Route of Administration	TRANSDERMAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	240 mg
Menthol, unspecified form (UNII: L7T10EIP3A) (Menthol, unspecified form - UNII:L7T10EIP3A)	Menthol, unspecified form	60 mg

Ingredient Name	Strength
Inactive Ingredients
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, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66902-220-05	5 in 1 BOX	12/18/2019
1		1 in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/18/2019

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Name	Address	ID/FEI	Business Operations
Establishment
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE(66902-220)

Revised: 12/2019

Document Id: 04c9f4cc-85f3-4daf-a7fd-45a31f6b86ab

Set id: 77978069-a1b4-473e-83c9-8320e00eea89

Version: 1

Effective Time: 20191218

NATURAL ESSENTIALS, INC.