Firstline Medical The I-stick Povidone-iodine Antiseptic Ampules

Firstline Medical The I-stick Povidone-iodine Antiseptic Ampules
SPL v1
SPL
SPL Set ID c2166cc2-0878-4e71-8b51-7df5046416f4
Route
TOPICAL
Published
Effective Date 2014-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Sodium Phosphate, Dibasic, Anhydrous Nonoxynol-9 Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-01-15

Description

Povidone-iodine 10%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-iodine 10%

Uses
  • Patient preoperative skin preparation
  • For preparation of the skin prior to surgery
  • Helps to reduce bacteria that potentially can cause skin infection

Warnings

For external use only.

Directions
  • clean the area
  • reverse cardboard sleeve then crush at dot between thumb and forefinger
  • allow solution to saturate tip
  • apply product to the operative site prior to surgery using the applicator tip

Do Not Use
  • in the eyes

Questions?

call 1-866-433-2131 Monday through Friday 9:00am-5:00pm est

Active Ingredient

Povidone-iodine 10%

Other Information
  • Store at room temperature away from light
  • Keep from freezing or excessive heat

Inactive Ingredients
  • citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
When Using This Product

keep out of eyes, ears, and mouth

Stop Use and Ask A Doctor If
  • irritation and redness develop
  • condition persists for more than 72 hours
  • infection occurs

Keep Out of Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.
Firstline Medical the I Stick Povidone Iodine Antiseptic Ampules

Line Medical the I Stick Povidone Iodine Antiseptic Ampules 25 Count (41477 420 69)
  • Representative Package Labeling







Structured Label Content

Uses
  • Patient preoperative skin preparation
  • For preparation of the skin prior to surgery
  • Helps to reduce bacteria that potentially can cause skin infection

Purpose

Antiseptic

Warnings

For external use only.

Directions
  • clean the area
  • reverse cardboard sleeve then crush at dot between thumb and forefinger
  • allow solution to saturate tip
  • apply product to the operative site prior to surgery using the applicator tip

Do Not Use (Do not use)
  • in the eyes

Questions?

call 1-866-433-2131 Monday through Friday 9:00am-5:00pm est

Active Ingredient (Active ingredient)

Povidone-iodine 10%

Other Information (Other information)
  • Store at room temperature away from light
  • Keep from freezing or excessive heat

Inactive Ingredients (Inactive ingredients)
  • citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
When Using This Product (When using this product)

keep out of eyes, ears, and mouth

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation and redness develop
  • condition persists for more than 72 hours
  • infection occurs

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.
Firstline Medical the I Stick Povidone Iodine Antiseptic Ampules (FIRSTLINE MEDICAL the i-stick Povidone-Iodine Antiseptic Ampules)

Line Medical the I Stick Povidone Iodine Antiseptic Ampules 25 Count (41477 420 69) (LINE MEDICAL the i-stick Povidone-Iodine Antiseptic Ampules 25 count (41477-420-69))
  • Representative Package Labeling







Advanced Ingredient Data


Raw Label Data

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