Sinsinpas Lidocaine Pain Relieving Patch

Sinsinpas Lidocaine Pain Relieving Patch
SPL v28
SPL
SPL Set ID 82c0a036-8750-5b3d-e053-2a91aa0a1815
Routes
CUTANEOUS TOPICAL TRANSDERMAL
Published
Effective Date 2019-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (280 mg)
Inactive Ingredients
Isopropyl Myristate Butylated Hydroxytoluene Glycerin

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: white Size: 14 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-05-25

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

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

Active Ingredients

Lidocaine 4%

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

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)

Sinsinpas Lidocaine Pain Relieving Patch


Structured Label Content

Uses

For the temporarily relief of minor pain

Purpose

Topical Anesthetic

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

Active Ingredients

Lidocaine 4%

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

Keep Out of Reach of Children Or Pets (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)

Sinsinpas Lidocaine Pain Relieving Patch (SINSINPAS LIDOCAINE PAIN RELIEVING PATCH)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)