Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 72a392df-2f86-4955-8972-a249c1c34395
Route
TOPICAL
Published
Effective Date 2009-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Povidone-iodine (.10 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2004-12-02

Description

Povidone Iodine,10% w/v (equivalent to 1% titratable iodine)

Purpose

Antiseptic


Medication Information

Warnings and Precautions



Purpose

Antiseptic

Description

Povidone Iodine,10% w/v (equivalent to 1% titratable iodine)

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

Do Not
  • use in the eyes
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body

Section 42229-5



Section 50567-7



Section 50568-5



Section 53413-1



Section 53414-9



Warnings

For external use only.

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

Active Ingredient

Povidone Iodine,10% w/v (equivalent to 1% titratable iodine)

Label Information

NDC 41250-677-94

meijer



Iodine

Topical

Solution

povidone iodine USP, 10%



TOPICAL ANTISEPTIC

HELPS PREVENT INFECTION IN MINOR CUTS, SCRAPES AND BURNS

WATER SOLUABLE

MEIJER PHARMACIST RECOMMENDED

COMPARE TO BETADINE®

active ingredient*

8 FL OZ (236 mL)

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

*This product is not manufactured of distributed by Purdue Frederick, owner of the registered trademark, Betadine®.





Other Information
Store at room temperature 15° - 30° C (59° - 86° F)

Inactive Ingredients
citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide
Ask A Doctor in Case Of
  • deep or puncture wounds
  • animal bites
  • serious burns

Keep Out of Reach of Children

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

Discontinue Use and Ask A Doctor
  • if condition persists or gets worse
  • for use longer than 1 week


Structured Label Content

Use (USE)
First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns

Do Not (Do not)
  • use in the eyes
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body

Warnings and Precautions (34071-1)



Section 42229-5 (42229-5)



Section 50567-7 (50567-7)



Section 50568-5 (50568-5)



Section 53413-1 (53413-1)



Section 53414-9 (53414-9)



Purpose (PURPOSE)

Antiseptic

Warnings (WARNINGS)

For external use only.

Directions (DIRECTIONS)
  • Clean the affected area
  • Apply a small amount of this product to 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% w/v (equivalent to 1% titratable iodine)

Label Information (LABEL INFORMATION)

NDC 41250-677-94

meijer



Iodine

Topical

Solution

povidone iodine USP, 10%



TOPICAL ANTISEPTIC

HELPS PREVENT INFECTION IN MINOR CUTS, SCRAPES AND BURNS

WATER SOLUABLE

MEIJER PHARMACIST RECOMMENDED

COMPARE TO BETADINE®

active ingredient*

8 FL OZ (236 mL)

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

*This product is not manufactured of distributed by Purdue Frederick, owner of the registered trademark, Betadine®.





Other Information (OTHER INFORMATION)
Store at room temperature 15° - 30° C (59° - 86° F)

Inactive Ingredients (INACTIVE INGREDIENTS)
citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide
Ask A Doctor in Case Of (Ask a doctor in case of)
  • deep or puncture wounds
  • animal bites
  • serious burns

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.

Discontinue Use and Ask A Doctor (Discontinue use and ask a doctor)
  • if condition persists or gets worse
  • for use longer than 1 week


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)