private label povidone iodine spray 5%

private label povidone iodine spray 5%
SPL v4
SPL
SPL Set ID a7bb80c4-bbc0-21ea-e053-2995a90a52c1
Route
topical
Published
Effective Date 2020-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
iodine (50 mg)
Inactive Ingredients
potassium iodate citric acid monohydrate sodium phosphate, dibasic glycerin water poloxamer 407 sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-01-23
Purpose

Antiseptic

Description

Povidone-Iodine 5% (0.5% available iodine)

Medication Information

Warnings

For external use only.

Uses

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns
Purpose

Antiseptic

Other Information

Store at 25°C (77°F); Excursions permitted between 15-30°C (59-86°F). Do not freeze.

Description

Povidone-Iodine 5% (0.5% available iodine)

Principal Display Panel

Section 42229-5

Drug Facts

Directions:
  • Clean the affected area
  • Spray a small amount of product on the area 1 to 3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first
Do Not Use:
  • In the eyes
  • Over large areas of the body
  • If you are allergic to povidone-iodine or any other ingredients in this preparation
Active Ingredient

Povidone-Iodine 5%

(0.5% available iodine)

Inactive Ingredients:

citric acid, disodium phosphate, glycerin, poloxamer 407, potassium iodata, purified water, sodium hydroxide.

Stop and Ask A Doctor If:
  • The condition persists or gets worse
  • You need to use this product for more that 1 week
Keep Out of Reach of Children

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

Ask A Doctor Before Use If You Have:
  • Deep or puncture wounds
  • Serious burns
  • Animal bites

Structured Label Content

Warnings

For external use only.

Uses

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns
Purpose

Antiseptic

Other Information

Store at 25°C (77°F); Excursions permitted between 15-30°C (59-86°F). Do not freeze.

Principal Display Panel

Section 42229-5 (42229-5)

Drug Facts

Directions:
  • Clean the affected area
  • Spray a small amount of product on the area 1 to 3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first
Do Not Use: (Do not use:)
  • In the eyes
  • Over large areas of the body
  • If you are allergic to povidone-iodine or any other ingredients in this preparation
Active Ingredient

Povidone-Iodine 5%

(0.5% available iodine)

Inactive Ingredients: (Inactive ingredients:)

citric acid, disodium phosphate, glycerin, poloxamer 407, potassium iodata, purified water, sodium hydroxide.

Stop and Ask A Doctor If: (Stop and ask a doctor if:)
  • The condition persists or gets worse
  • You need to use this product for more that 1 week
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.

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)
  • Deep or puncture wounds
  • Serious burns
  • Animal bites

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:31.890949 · Updated: 2026-03-14T23:02:08.105317