First Aid Antiseptic Ointment

First Aid Antiseptic Ointment
SPL v4
SPL
SPL Set ID b2bcb69e-8ffb-23ee-e053-2995a90aee21
Route
TOPICAL
Published
Effective Date 2025-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Polyethylene Glycol 400 Polyethylene Glycol 4000

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-03

Description

Povidone Iodine USP 10% w/w (available iodine 1%)

Purpose

First aid antiseptic


Medication Information

Purpose

First aid antiseptic

Description

Povidone Iodine USP 10% w/w (available iodine 1%)

Uses

first aid to help prevent infection in minor:

  • cuts 
  • scrapes 
  • burns
Warnings

For external use only.

Directions
  • clean the affected area 
  • apply a small amount of this product on the area 1 to 3 times daily 
  • may be covered with a sterile bandage
Do Not Use
  • if you are allergic to any of the ingredients
  • over large areas of the body 
  • longer than 1 week unless directed by a doctor 
  • in the eyes
Drug Facts

Active Ingredient

Povidone Iodine USP 10% w/w (available iodine 1%)

Other Information
  • store at controlled room temperature 20° to 25°C (68° to 77°F) 
  • close cap tightly after use
Package Labeling:

Inactive Ingredients

Polyethylene Glycol 400, Polyethylene Glycol 4000

Questions Or Comments?

1-800-639-3803

Stop Use and Ask A Doctor If

condition persists or gets worse

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have
  • deep or puncture wounds 
  • animal bites 
  • serious burns

Structured Label Content

Uses

first aid to help prevent infection in minor:

  • cuts 
  • scrapes 
  • burns
Purpose

First aid antiseptic

Warnings

For external use only.

Directions
  • clean the affected area 
  • apply a small amount of this product on the area 1 to 3 times daily 
  • may be covered with a sterile bandage
Do Not Use (Do not use)
  • if you are allergic to any of the ingredients
  • over large areas of the body 
  • longer than 1 week unless directed by a doctor 
  • in the eyes
Drug Facts

Active Ingredient (Active ingredient)

Povidone Iodine USP 10% w/w (available iodine 1%)

Other Information (Other information)
  • store at controlled room temperature 20° to 25°C (68° to 77°F) 
  • close cap tightly after use
Package Labeling:

Inactive Ingredients (Inactive ingredients)

Polyethylene Glycol 400, Polyethylene Glycol 4000

Questions Or Comments? (Questions or comments?)

1-800-639-3803

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition persists or gets worse

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds 
  • animal bites 
  • serious burns

Advanced Ingredient Data


Raw Label Data

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