drug facts

drug facts
SPL v3
SPL
SPL Set ID 4c47327a-3d31-4cf3-ae81-6a20976197fb
Route
topical
Published
Effective Date 2015-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
iodine (1 g)
Inactive Ingredients
nonoxynol-9 water sodium phosphate, dibasic, anhydrous citric acid monohydrate sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2015-08-26

Purpose

Antiseptic/First Aid Antispetic

Description

Povidone Iodine 10% (equivalent to 1% titratable iodine)


Medication Information

Warnings

For External Use Only.



Uses
  • First aid to help prevent skin infection in minor cuts,scrapes, and burns
  • For preparation of the skin prior to skin surgery
  • Helps to reduce bacteria that can potentially cause skin infection

Purpose

Antiseptic/First Aid Antispetic



Other Information
  • Protect from freezing

  • Avoid excessive heat



Description

Povidone Iodine 10% (equivalent to 1% titratable iodine)

Principal Display Panel

Povidone-Iodine Prep Solution

Povidone-Iodine 10%

single use only

Cardinal Health

Net Wt. 0.75 fl oz (22.2 mL)

NDC 63517-132-01











Section 50566-9


Section 50569-3


Do Not Use

As a first aid antiseptic





  • Do not use in the eyes or apply over large areas of the body
  • In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor
  • Stop use and consult a doctor if the condition persists or gets worse
  • Do not use longer than 1 week unless directed by a doctor


For preoperative patient skin preparation





  • Do not use in the eyes
  • Discontinue use if irritation and redness develop
  • If condition persists for more than 72 hours, consult a doctor



Directions:

Clean the affected area.





For preparation of skin prior to surgery

  • Apply product to the operative site prior to surgery

For first aid antiseptic

  • Apply a small amount of this product on the area 1-3 times daily.
  • May be covered with a sterile bandage.
  • If bandaged, let dry first.







Active Ingredient

Povidone Iodine 10%

(equivalent to 1% titratable iodine)



Inactive Ingredients:

Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water



Keep Out of Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.



Structured Label Content

Warnings

For External Use Only.



Uses
  • First aid to help prevent skin infection in minor cuts,scrapes, and burns
  • For preparation of the skin prior to skin surgery
  • Helps to reduce bacteria that can potentially cause skin infection

Purpose

Antiseptic/First Aid Antispetic



Other Information (Other information)
  • Protect from freezing

  • Avoid excessive heat



Principal Display Panel

Povidone-Iodine Prep Solution

Povidone-Iodine 10%

single use only

Cardinal Health

Net Wt. 0.75 fl oz (22.2 mL)

NDC 63517-132-01











Section 50566-9 (50566-9)


Section 50569-3 (50569-3)


Do Not Use (Do not use)

As a first aid antiseptic





  • Do not use in the eyes or apply over large areas of the body
  • In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor
  • Stop use and consult a doctor if the condition persists or gets worse
  • Do not use longer than 1 week unless directed by a doctor


For preoperative patient skin preparation





  • Do not use in the eyes
  • Discontinue use if irritation and redness develop
  • If condition persists for more than 72 hours, consult a doctor



Directions:

Clean the affected area.





For preparation of skin prior to surgery

  • Apply product to the operative site prior to surgery

For first aid antiseptic

  • Apply a small amount of this product on the area 1-3 times daily.
  • May be covered with a sterile bandage.
  • If bandaged, let dry first.







Active Ingredient (Active ingredient)

Povidone Iodine 10%

(equivalent to 1% titratable iodine)



Inactive Ingredients:

Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water



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.



Advanced Ingredient Data


Raw Label Data

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