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  5. Label Information: Sinsinpas Lidocaine Pain Relieving

FDA Label for Sinsinpas Lidocaine Pain Relieving

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN OR PETS
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. SINSINPAS LIDOCAINE PAIN RELIEVING PATCH

Sinsinpas Lidocaine Pain Relieving Product Label

The following document was submitted to the FDA by the labeler of this product Sinsin Pharmaceutical Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Lidocaine 4%


Purpose



Topical Analgesic


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 undress 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


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