SINSINPAS LIDOCAINE PAIN RELIEVING PATCH

SINSINPAS LIDOCAINE PAIN RELIEVING by

Drug Labeling and Warnings

SINSINPAS LIDOCAINE PAIN RELIEVING by is a Otc medication manufactured, distributed, or labeled by Sinsin Pharmaceutical Co., Ltd, Sinsin Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SINSINPAS LIDOCAINE PAIN RELIEVING- lidocaine patch 
Sinsin Pharmaceutical Co., Ltd

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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SINSINPAS LIDOCAINE PAIN RELIEVING PATCH

Active ingredient

Lidocaine 4%

Purpose.... Topical anesthetic

Uses

For temporary relief of minor pain

Warnings

For external use only

Do not use

more than 1 patch at a time

on broken, 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 label

Avoid contact with the eyes or mucous membranes - Do not apply to broken, damaged, or irritated skin Do not bandage tightly or apply local heat (such as heating pads) to the area of use

Rare cases of serious burns have been reported with products of this type

Do not use with other topical analgesics

Keep children and pets away from used or disposed patch. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this product.

Stop use and ask a doctor if

condition worsens

irritation develops

redness is present

symptoms persist for more than 7 days or clear up and occur again within a few days

any signs of skin injury appear at the site of the product application such as pain, swelling, bruising, or blistering

If pregnant or breastfeeding, ask a physician before use.

Keep out of reach of children or pets. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Other information

avoid storing in direct sunlight

protect product from excess moisture

store at room temperature.

Do not exceed 86° Fahrenheit, 30° Celsius

Directions

Adults/children 12 years of age and over

clean and dry affected area

remove film from patch by gently pulling apart from corner

carefully apply to affected area

once patch is positioned, press firmly to adhere to skin

use only one patch at a time for up to 12 hours

Ask a doctor

Children under 12 years of age: consult a healthcare professional

Inactive ingredients

butylated hydroxytoluene, carboxymethylcellulose sodium, Concentrated Glycerin, Disodium edetate Hydrate

isopropyl myristate, kaolin, magnesium aluminosilicate, Nikazole TS-620,

methyl paraben, polyacrylic acid solution, polysorbate 80, propylene glycol, propyl paraben, purified water,

sodium polyacrylate, sorbitan sesquioleate, tartaric acid, titanium dioxide, urea, D-sorbitol solution,

Purpose

Topical anesthetic

Uses

For temporary relief of minor pain

Do not use

more than 1 patch at a time

on broken, irritated, or swollen skin

on puncture wounds

for more than one week without consulting a doctor

SINSINPAS

MAXIMUM STRENGTH

LIDOCAINE 4% PAIN RELIEVING PATCH

TARGETS PAIN FOR QUICK RELIEF

PERETRATES NERVE RECEPTORS TO NUMB AND DESENSITIZE

LONG LASTING AND UNSCENTED

EASY TO APPLY

5 PATCHES

3.93 IN X 5.51 IN, EACH

ODOR FREE

SINSINPAS LIDOCAINE PAIN RELIEF PATCH

SINSINPAS LIDOCAINE PAIN RELIEVING 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55264-106
Route of AdministrationTOPICAL, CUTANEOUS, TRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE560 mg  in 14 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorwhiteScore    
ShapeRECTANGLESize14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55264-106-045 in 1 BOX05/25/201702/04/2022
1NDC: 55264-106-021 in 1 POUCH
1NDC: 55264-106-0114 g in 1 PATCH; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/25/201702/04/2022
Labeler - Sinsin Pharmaceutical Co., Ltd (823149161)
Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)

Revised: 2/2022