PRO COMFORT 8 HOURS PATCH- lidocaine patch 4% patch

Pro Comfort 8 Hours Patch by

Drug Labeling and Warnings

Pro Comfort 8 Hours Patch by is a Otc medication manufactured, distributed, or labeled by CARE LIVING DIAGNOSTICS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Product Information

Active Ingredient

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Purpose

Topical Anesthetic

Uses

for the temporary relief of pain

Warnings

For external use only

Do not use

• more than 1 patch on your body at a time
• on puncture wounds,
• on cuts, irritated or swollen skin
• 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
• 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
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness or irritation develops
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Adults and children over 12 years:

• wish and dry affected area
• Peel off the backing fim from one side of the patch carefully
• Apply the exposed portion of the patch to the affected area
• Gently press the patch with your hand to fit the affected area completely
• Do not exercise vigorously during use to prevent the patch from falling off
• use only 1 patch for a maximum of 8 hours

children under 12 years of age: Ask a doctor before use

Other Information

store at room temperature 15°-30°C (59°-86°F).

Inactive ingredients

aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water

Questions or Comments?
E-mail: info@carelivingusa.com

Child-Resistant Packaging
Manufactured for

CARE LIVING DIAGNOSTICS INC.

Www.carelivingusa.com

Made in China

Active Ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

for the temporary relief of pain

Warnings

For external use only

Do not use

• more than 1 patch on your body at a time
• on puncture wounds,
• on cuts, irritated or swollen skin
• 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
• 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
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness or iritation develops
• you experience signs of skin injury, such as pain, swelling, or blistering wherethe product was applied

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children and pets.

lf swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222)

Directions

Adults and children 12 years of age and older:

• Wash and dry the affected area.
• Peel off the backing film from one side of the patch carefully.
• Apply the exposed portion of the patch to the affected area.
• Gently press the patch with your hand to fit the affected area completely.
• Do not exercise vigorously during use to prevent the patch from falling off.
• Ues only 1 patch for a maximum of 8 hours.

children under 12 years of age:Ask a doctor before use.

Other Information

store at room temperature 15°-30°C (59°-86°F).

Inactive ingredients

aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water

Questions or Comments?

E-mail:info@carelivingusa.com

Manufactured for:

CARE LIVING DIAGNOSTICSINC

www.carelivingusa.com

Made in China

Dosage

0.246 g in 1 PATCH,5 PATCH in 1 CARTON

PRINCIPAL DISPLAY PANEL

Pro Comfort 8 Hour Lidocaine Patch

INGREDIENTS AND APPEARANCE

PRO COMFORT 8 HOURS PATCH 
lidocaine patch 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83568-4643
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
UREA (UNII: 8W8T17847W)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83568-4643-5	5 in 1 BOX	08/01/2023
1	NDC: 83568-4643-1	4 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 not final	part348	08/01/2023

Labeler - CARE LIVING DIAGNOSTICS INC (125354643)