Dosage & Administration
Snap at the marked ring to release the solution, apply to the affected area.
Povidone-iodine Prep Swabsticks Swab
FDA Label NDC 85930-0201
11 label sections · Submitted to the FDA by Kingstar Medical (xianning) Co., Ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kingstar Medical (xianning) Co., Ltd. for the product Povidone-iodine Prep Swabsticks (NDC 85930-0201). 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 dosage & administration, inactive ingredient, indications & usage, instructions for use, otc - active ingredient, otc - purpose, otc - do not use, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Citric acid,Disodium phosphate,Purified water
Indications & Usage
First aid to help prevent infection in minor cuts, scrapes, and burns; preparation of the skin prior to surgery.
Instructions For Use
Clean the affected area
Tear open the pouch at the notch and remove the swabstick.
Snap the swabstick at the marked ring to release the solution into the cotton tip.
Apply a small amount to the affected area 1 to 3 times daily. May be covered with a sterile bandage (let dry first).
Single use only. Do not reuse.
Otc - Active Ingredient
Povidone-iodine 10% (equivalent to 1% available iodine)
Otc - Purpose
First aid antiseptic
Otc - Do Not Use
In the eyes
Over large areas of the body
On individuals who are allergic or sensitive to iodine
As a first aid antiseptic longer than 1 week unless directed by a doctor
Warnings
For external use only.
Do not use in the eyes, over large areas of the body, on individuals who are allergic or sensitiveto iodine, or for more than 1 week unless directed by a doctor.
Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.
When using this product, do not get into eyes.
Stop use and ask a doctor ifiritation and redness develop, or the condition persists or gets worse
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other Safety Information
Store at room temperature; protect from heat and direct sunlight.
Store at room tempertaure
Avoid excessive heat
For external use only
single use only
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label.Principal Display Panel
60 Count (60)
120 Count (120)
Benefits:
Skin prep & minor cuts, scrapes, burns
Helps prevent infection
Single-use, disposable
60 COUNT/120 COUNT
Individually Sealed Packets
Snap-to-Activate
100% Cotton Tip
Manufacturer: Kingstar Medical (Xianning) Co., Ltd
Address: No. 79 Yong’andong Road, Xian’an District 437100, Xianning City, Hubei Province, the People's Republic of China
Official Website: http://www.kingstarmedical.cn/
E-mail: [email protected]
Tel: 86 - 715 - 8911850
made in china
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