CVS HEALTH LIDOCAINE PAIN-RELIEVING- lidocaine kit

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., Foshan Aqua Gel Biotech, Co., Ltd.. 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 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 use more than one patch in an 8 hour period. Maximum 3 patches per day.
• 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
• NOTE:patches may not adhere as well to all individuals, skin types, or certain parts of the body.

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 feedingask 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 a avoid strenuous exercise while wearing patch, this will result in patch not sticking
• do not use more than one patch in an 8 hour period.

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 – Carton Label

CVS
Health ®

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

MAXIMUM STRENGTH

Lidocaine concentration
without a prescription †

Lidocaine
Pain-Relieving
Patches

LIDOCAINE 4% GEL

Desensitizes
aggravated nerves

• Fast acting
• Easy to apply
• No irritation or burning

Unscented

6ASSORTED SIZE PATCHES

2 SM 3 1/8” x 4 ¾” (8 cm x 12 cm)

2 MED 3 15/16” x 5 1/2” (10 cm x 14 cm)

2 XL 5 1/2” x 9 7/8” (14 cm x 25 cm)

Pain-relieving ointment on a breathable adhesive pad

EACH PATCH IS SEALED IN A CHILD-RESISTANT POUCH FOR SAFETY

ASSORTED
SIZES

Principal Display Panel – Small Patch Label

CUT OPEN POUCH AND REMOVE PATCH

CVS
Health ®

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

MAXIMUM STRENGTH

Lidocaine concentration without a prescription†

Lidocaine
Pain-Relieving
Patch

LIDOCAINE 4% GEL

Desensitizes aggravated nerves

• Fast acting
• Easy to apply
• No irritation or burning

Unscented

†Among over the counter
topical analgesics.

1PATCH | SMALL

3 1/8” x 4 3/4” (8 cm x 12 cm)

Principal Display Panel – Medium Patch Label

CUT OPEN POUCH AND REMOVE PATCH

CVS
Health®

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

MAXIMUM STRENGTH

Lidocaine concentration without a prescription†

Lidocaine
Pain-Relieving
Patch

LIDOCAINE 4% GEL

Desensitizes aggravated nerves

• Fast acting
• Easy to apply
• No irritation or burning

Unscented

†Among over the counter
topical analgesics.

1PATCH | MEDIUM

3 15/16” x 5 1/2” (10 cm x 14 cm)

Principal Display Panel – X Large Patch Label

CUT OPEN POUCH AND REMOVE PATCH

CVS
Health ®

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

MAXIMUM STRENGTH

Lidocaine concentration without a prescription†

Lidocaine
Pain-Relieving
Patch

LIDOCAINE 4% GEL

Desensitizes aggravated nerves

• Fast acting
• Easy to apply
• No irritation or burning

Unscented

†Among over the counter
topical analgesics.

1PATCH | X LARGE

5 1/2” x 9 7/8” (14 cm x 25 cm)

INGREDIENTS AND APPEARANCE

CVS HEALTH LIDOCAINE PAIN-RELIEVING 
lidocaine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-450

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-450-06	1 in 1 CARTON; Type 0: Not a Combination Product	06/02/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 PATCH	14 g
Part 2	2 PATCH	22 g
Part 3	2 PATCH	46 g

Part 1 of 3

CVS HEALTH LIDOCAINE PAIN-RELIEVING 
lidocaine patch

Product Information
Item Code (Source)	NDC: 66902-270
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

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, UNSPECIFIED (UNII: FZ989GH94E)
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: 66902-270-04	1 in 1 POUCH
1		7 g 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 Drug	M017	06/02/2020

Part 2 of 3

CVS HEALTH LIDOCAINE PAIN-RELIEVING 
lidocaine patch

Product Information
Item Code (Source)	NDC: 66902-270
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

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, UNSPECIFIED (UNII: FZ989GH94E)
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: 66902-270-05	1 in 1 POUCH
1		11 g 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 Drug	M017	06/02/2020

Part 3 of 3

CVS HEALTH LIDOCAINE PAIN-RELIEVING 
lidocaine patch

Product Information
Item Code (Source)	NDC: 66902-270
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

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, UNSPECIFIED (UNII: FZ989GH94E)
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: 66902-270-06	1 in 1 POUCH
1		23 g 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 Drug	M017	06/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/02/2020

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech, Co., Ltd.		529128763	manufacture(66902-450, 66902-270)