1108 Povidone Iodine Prep Pad Ndc 67777-002-01

1108 Povidone Iodine Prep Pad Ndc 67777-002-01
SPL v7
SPL
SPL Set ID 81b475e8-8da4-7b15-e053-2991aa0a6629
Route
TOPICAL
Published
Effective Date 2024-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 g)
Inactive Ingredients
Glycerin Water Polysorbate 80 Sodium Citrate Sodium Phosphate, Dibasic Anhydrous Citric Acid

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-17

Description

Povidone-Iodine USP 10% w/v (9.85% w/w)

Purpose

First Aid Antiseptic


Medication Information

Purpose

First Aid Antiseptic

Description

Povidone-Iodine USP 10% w/v (9.85% w/w)

Label

Use(s)

First aid to help prevent the risk of infection in minor cuts, scrapes, and burns

Warnings

For External Use Only

Directions
  • Tear at notch
  • Remove prep pad
  • Apply a small amount of this product on the area 1 to 3 times daily.
  • May be covered with a sterile bandage
  • If bandaged, let dry first
  • Use only once

Do Not Use

• In the eyes or over large areas of the body

• Longer than one week unless directed by a doctor

Label 1108ub 10

1108UB-10

Active Ingredient

Povidone-Iodine USP 10% w/v (9.85% w/w)

Other Information
  • Store at room temperature 15º-30ºC (59º-86ºF)
  • Flammable. Keep away from fire or flame
Inactive Ingredients

Anhydrous Citric Acid, Glycerin, Polysorbate 80, Sodium Citrate USP, Sodium Phosphate Dibasic, Water

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

Label

Use(s)

First aid to help prevent the risk of infection in minor cuts, scrapes, and burns

Purpose

First Aid Antiseptic

Warnings

For External Use Only

Directions
  • Tear at notch
  • Remove prep pad
  • Apply a small amount of this product on the area 1 to 3 times daily.
  • May be covered with a sterile bandage
  • If bandaged, let dry first
  • Use only once

Do Not Use (Do not use)

• In the eyes or over large areas of the body

• Longer than one week unless directed by a doctor

Label 1108ub 10 (Label 1108UB-10)

1108UB-10

Active Ingredient

Povidone-Iodine USP 10% w/v (9.85% w/w)

Other Information
  • Store at room temperature 15º-30ºC (59º-86ºF)
  • Flammable. Keep away from fire or flame
Inactive Ingredients

Anhydrous Citric Acid, Glycerin, Polysorbate 80, Sodium Citrate USP, Sodium Phosphate Dibasic, Water

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

All Sections (JSON)