Povidone-iodine Prep Pad
FDA Label NDC 44019-211
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yinjing Medical Technology (shanghai) Co., Ltd. for the product Povidone-iodine Prep Pad (NDC 44019-211). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, use, stop use section, warnings section, keep out of reach of children section, directions section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Povidone-Iodine 10% w/w
(1% titratable iodine)
Purpose
Antiseptic
Use
First aid antiseptic to help prevent infection in scrapes, minor cuts and burns Antiseptic to prepare skin prior to surgery. Uses antiseptic skin preparation
Stop Use Section
Stop use and ask a doctor if skin irritation, redness, swelling, or pain occurs.
Warnings Section
Warnings • Do not use if allergic to iodine • For external use only • Do not use in eyes • Avoid pooling beneath patient • In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Keep Out Of Reach Of Children Section
Keep out of reach of children.
Directions Section
Directions apply locally as needed
Inactive Ingredients Section
Inactive ingredients Sodium hydroxide, water
Other Information Section
Other information
For Hospital or Professional Use Only.
Store at room temperature: 15℃- 30 ℃
Other
Shanghai Yinjing Medical Supplies Co., Ltd.
No.586 Yuanxi RD.Nanhui Industry Park,Shanghai 201300
Tel:+86-21-68016633 Http://www.yinjing.cn
Made in China
LOT EXP.
Package Label.Principal Display Panel
inin
NDC:44019-211-01
1 pad/pouch
POVIDONE-IODINE PREP PAD
For External Use Only
* Please review the disclaimer below.
