SINSINPAS LIDOCAINE PAIN RELIEVING- lidocaine 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]

Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Keep out of reach of children or pets

Keep out of reach of children or pets.

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

Uses

For the temporarily 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 direction and warning 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.

Directions

Adults and 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 afftcted area
• once patch is positioned, press firmly to adhere to skin
• use only one patch at a time for up the 12 hours

Children under 12 years of age: consult a professional

Inactive Ingredients

butylated hydroxytoluene
carboxymethylcellulose sodium
glycerin
edetate disodium
isopropyl myristate
kaolin
magnesium aluminosilicate
methyl acrylate and 2-ethylhexyl acrylate copolymer aqueous emulsion (mixture)
methyl paraben
polyacrylic acid
polysorbate 80
propylene glycol
propyl paraben
purified water
sodium polyacrylate
sorbitan sesquioleate
tartaric acid
urea

SINSINPAS LIDOCAINE PAIN RELIEVING PATCH

INGREDIENTS AND APPEARANCE

SINSINPAS LIDOCAINE PAIN RELIEVING 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55264-106
Route of Administration	TOPICAL, CUTANEOUS, TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	560 mg  in 14 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	280 mg  in 14 g
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCERIN (UNII: PDC6A3C0OX)	3500 mg  in 14 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55264-106-03	5 in 1 BOX	05/25/2017
1	NDC: 55264-106-02	1 in 1 POUCH
1	NDC: 55264-106-01	14 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	05/25/2017

Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)

Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)

Establishment
Name	Address	ID/FEI	Business Operations
Sinsin Pharmaceutical Co., Ltd.		687867143	manufacture(55264-106)