globe povidone iodine usp 10%

globe povidone iodine usp 10%
SPL v2
SPL
SPL Set ID f80ccd8a-9b9b-bbf9-e053-6394a90ac827
Route
topical
Published
Effective Date 2022-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
iodine (100 mg)
Inactive Ingredients
polyethylene glycol 4000 polyethylene glycol 400

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-12-23

Purpose

First Aid Antiseptic

Description

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


Medication Information

Warnings

For external Use Only

Do not use

  • in eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
Uses

First Aid to help prevent infection in minor cuts, scrapes and burns.

Purpose

First Aid Antiseptic

Directions
  • Clean the affected area
  • apply a small amount of this product (equal to the surface area of a fingertip) to the area 1 to 3 times daily.
  • may be covered with a sterile bandage
Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Inactive Ingredients

Polyethylene glycol 400, Polyethylene glycol 4000

Description

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

Questions?

Call 1-888-296-9067

Section 51945-4

Questions

1-888-296-9067

Active Ingredient

Povidone Iodine USP 10%

w/w (available iodine 1%)

Storage Information

  • Store at controlled room temperature 20º to 25ºC (68ºF to 77ºF).
  • close cap tightly after use.
Stop Use and Ask A Doctor If
  • The condition persists or gets worse
  • you need to use this product for more than 1 week
Keep Out of Reach of Children

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

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

Structured Label Content

Warnings

For external Use Only

Do not use

  • in eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
Uses

First Aid to help prevent infection in minor cuts, scrapes and burns.

Purpose

First Aid Antiseptic

Directions
  • Clean the affected area
  • apply a small amount of this product (equal to the surface area of a fingertip) to the area 1 to 3 times daily.
  • may be covered with a sterile bandage
Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Inactive Ingredients

Polyethylene glycol 400, Polyethylene glycol 4000

Questions?

Call 1-888-296-9067

Section 51945-4 (51945-4)

Questions

1-888-296-9067

Active Ingredient

Povidone Iodine USP 10%

w/w (available iodine 1%)

Storage Information

  • Store at controlled room temperature 20º to 25ºC (68ºF to 77ºF).
  • close cap tightly after use.
Stop Use and Ask A Doctor If (Stop Use and Ask a doctor if)
  • The condition persists or gets worse
  • you need to use this product for more than 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 immediately (1-800-222-1222) right away.

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)