Povidone-iodine Prep Pad
FDA Label NDC 54429-0104

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Foshan Flying Medical Products Co., Ltd. for the product Povidone-iodine Prep Pad (NDC 54429-0104). 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 ingredient, purpose, caution: keep out of reach of children, indications and usage section, warnings, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 notuse

﹒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

Active Ingredient

Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Purpose

Antiseptic

Caution: Keep Out Of Reach Of Children

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

Indications And Usage Section

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 notuse

﹒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.

Directions

Apply product on the area 1-3 times daily and discard.

Inactive Ingredient

ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

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