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Povidone-iodine prep pad - Medication Information

Product NDC Code 71584-0104
Drug Name

Povidone-iodine prep pad

Type Brand
Active Ingredients
Povidone-iodine 9.43 g/100g
Route TOPICAL
Dosage Form SWAB
Application Number M003
Labeler Name Guangdong Comfort Medical Products Co., Ltd.
Packages
Package NDC Code Description
71584-0104-1 9.43 g in 1 pouch (71584-0104-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Apply product on the area 1-3 times daily and discard.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENT ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Indications and usage section First aid to help prevent infection in minor cuts, scrapes, and burns

Purpose

Information about the drug product’s indications for use.
Purpose Antiseptic

Spl product data elements

Usually a list of ingredients in a drug product.
Povidone-iodine prep pad povidone-iodine WATER CITRIC ACID MONOHYDRATE SODIUM HYDROXIDE POVIDONE-IODINE IODINE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
DRUG FACTS Active ingredient Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine) Purpose Antiseptic Use First aid to help prevent infection in minor cuts, scrapes, and burns Warnings For external use only. Flammable, keep away from fire or flame. Do not use ﹒in the eyes or apply over large areas of the body. ﹒on individuals who are allergic or sensitive to iodine. Stop use If irritation, redness or other symptoms develop. Ask a doctor If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns. CAUTION: Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. Directions Apply product on the area 1-3 times daily and discard. Other information: Store at room temperature. Inactive ingredients ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide image of carton image of packet

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
CAUTION: Keep out of reach of children If swallowed, get medical help or contact Poison Control Center right away.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
WARNINGS For external use only. Flammable, keep away from fire or flame. Do not use ﹒in the eyes or apply over large areas of the body. ﹒on individuals who are allergic or sensitive to iodine. Stop use If irritation, redness or other symptoms develop. Ask a doctor If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API