MedPath

Lights Povidone Iodine Scrub

61333-216 Lights POVIDONE-IODINE SCRUB

Approved
Approval ID

5e1eef53-c2c7-477e-9ee4-19c01c1881e5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

Lights Medical Manufacture Co., Ltd.

DUNS: 529128649

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

POVIDONE-IODINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61333-216
Application NumberM004
Product Classification
M
Marketing Category
C200263
G
Generic Name
POVIDONE-IODINE
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (5)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCEROL FORMALInactive
Code: 3L7GR2604E
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)Inactive
Code: 12VCE9HR9E
Classification: IACT
POVIDONE-IODINEActive
Quantity: 0.75 g in 100 g
Code: 85H0HZU99M
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/20/2025

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/20/2025

Use:

antiseptic skin preparation

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/20/2025

Inactive Ingredient

disodium hudrogen phsophate, glycerol, ammonium dodecyl ether sulfate, hydroxyethylcellulose, water

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/20/2025

Active Ingredient: Povidone-Iodine USP: 7.5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/20/2025

Purpose: Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/20/2025

Warnings:

Do not use if allergic to iodine

For external use only

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/20/2025

Ask a doctor before use if injuries are

  • deep or puncture wounds
  • serious burns

Stop use and ask a doctor if

  • redness, irritation, swelling, or pain persists or increases
  • infection occurs

Do not use in eyes

Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/20/2025

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/20/2025

Apply locally as need

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/20/2025

Other information

  • 0.75% available iodine
  • latex free
  • for hospital or professional use only

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Lights Povidone Iodine Scrub - FDA Drug Approval Details