Satohap Lidocaine 4% Pain Relieving Pad - Sato de-listing

Satohap Lidocaine 4% Pain Relieving Pad by

Drug Labeling and Warnings

Satohap Lidocaine 4% Pain Relieving Pad by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd., Nipro Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SATOHAP LIDOCAINE 4% PAIN RELIEVING PAD- lidocaine patch 
Sato Pharmaceutical Co., Ltd.

----------

Satohap Lidocaine 4% Pain Relieving Pad - Sato de-listing

Active ingredient

Lidocaine 4%

Purpose

Topical analgesic

Uses

For temporary relief of pain

Warnings

For external use only.

Do not use

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
  • in large quantities, particularly over raw surfaces or blistered areas

When using this product

  • use only as directed. Read and follow all directions and warnings on this carton.
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and ask a doctor if

  • condition worsens
  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children and pets.

If swallowed, get medical help or contact a poison Control Center right away.

Directions

adults and children over 12 years:

  • clean and dry affected area
  • peel off protective backing and apply sticky side to affected area
  • use 1 patch for up to 8 hours

children 12 years or younger: ask a doctor

Other information

  • avoid storing product in direct sunlight
  • protect product from excessive moisture
  • store at 68°-77°F (20°-25°C)

Inactive ingredients

carboxymethylcellulose sodium, diethylene glycol monoethyl ether, dihydroxyaluminum aminoacetate, edetate disodium, gelatin, glycerin, methylparaben, partially neutralized polyacrylate, phosphoric acid, polysorbate 80, polyvinyl alcohol, propylene glycol, propylparaben, sorbitol, tartaric acid, urea, water, on a breathable polyester fabric with a removable polypropylene protective cover

Satohap Lidocaine 4% Pain Relieving Pad

Satohap Lidocaine 4% Pain Relieving Pad (front)

Satohap Lidocaine 4% Pain Relieving Pad

Satohap Lidocaine 4% Pain Relieving Pad (back)

SATOHAP LIDOCAINE 4% PAIN RELIEVING PAD 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49873-617
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
UREA (UNII: 8W8T17847W)  
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TARTARIC ACID (UNII: W4888I119H)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49873-617-015 in 1 BOX11/01/202006/30/2024
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/01/202006/30/2024
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Nipro Corporation693328343manufacture(49873-617)

Revised: 11/2023
Document Id: 094a93d5-d88d-1d3f-e063-6294a90a3b3b
Set id: b1340e80-174a-124d-e053-2a95a90a4c7a
Version: 4
Effective Time: 20231103