FDA Label for Dual Swab Scrub Swabstick
View Indications, Usage & Precautions
Dual Swab Scrub Swabstick Product Label
The following document was submitted to the FDA by the labeler of this product Dynarex Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient Purpose
Povidone Iodine Scrub 7.5% w/w Antiseptic
Povidone Iodine Prep 10% w/w Antiseptic
Purpose
Uses
Povidone Iodine Scrub Swabstick - For scrubbing procedure site, prior to antiseptic application.
Povidone Iodine Prep Swabstick - For antiseptic application at procedure site.
Indications & Usage
Indications and Usage
- For pre-operative patient skin preparation.
Warnings
For External Use Only
Avoid contact with eyes. If contact occurs, flush with water.
Stop Use
Stop use and ask a healthcare professional if;
- condition worsens or persists for more than 72 hours
- if pain, irritation, redness or swelling occurs
Ask A Doctor
Ask a doctor before use if you have:
- deep puncture wounds
- animal bites
- serious wounds
Otc - Do Not Use
Do Not Use:
- as a first aid antiseptic for more than 1 week
- over large areas of the body
Otc - Keep Out Of Reach Of Children
Keep Out Of Reach Of Children
- if swallowed, get medical help or contact a Poison Control Center immediately.
Dosage And Administration
Directions
For pre-operative patient skin preparation:
- Apply to procedure site and allow to dry.
- discard after single use.
- If not ready for immediate venipuncture, cover the area with a dry sterile gauze.
- clean affected area
- apply to wound once or twice daily
- may be covered with a sterile bandage
- if bandaged let dry first
As a first aid antiseptic:
Tear at notch, remove applicator, use only once.
Inactive Ingredients
- Povidone Iodine 7.5% Scrub Solution - Lauramide DEA, water
- Povidone Iodine 10% Prep Solution - Anhydrous citric acid, disodium hydrogen phosphate, water
Other Information
- Store at room temperature
- Avoid excessive heat
Principal Display Panel
Dynarex Dual Swab Prep and Scrub Kit
Item 1207
1207_pouches.jpg
* Please review the disclaimer below.