NDC | 55264-106-01, 55264-106-02, 55264-106-03 |
Set ID | 82c0a036-8750-5b3d-e053-2a91aa0a1815 |
Category | HUMAN OTC DRUG LABEL |
Packager | Sinsin Pharmaceutical Co., Ltd. |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- Active Ingredients
- Purpose
- Keep out of reach of children or pets
- Uses
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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
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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
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INGREDIENTS AND APPEARANCE
SINSINPAS LIDOCAINE PAIN RELIEVING
lidocaine patchProduct 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)