PHARMA CARE PRO STERILE PREP SWABSTICK POVIDONE-IODINE- povidone-iodine swab

PHARMA CARE Pro Sterile Prep Swabstick POVIDONE-IODINE by

Drug Labeling and Warnings

PHARMA CARE Pro Sterile Prep Swabstick POVIDONE-IODINE by is a Otc medication manufactured, distributed, or labeled by Enviro Specialty Chemicals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active ingredients

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

Purposes

Antiseptic

Use

For the preparation of a patient’s skin prior to surgery, injection, venipuncture/phlebotomy procedural sites, to reduce the risk of bacterial and skin infection, when used as directed.

Warnings:

For external use only. Single use only. For Professional Health Care providers use only. Flammable: keep away from fire or flame.

Do not use
on patients with known allergies to Iodine
for lumbar puncture or in contact with the meninges
on open skin wounds or as a general skin cleanser

Do not use with electrocautery procedure.

When using this product, keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions for Use

use with care in premature infants or infants under 2 months of age — these products may cause irritation or chemical burns.
maximal recommended treatment area using:
    one single swab stick applicator: approx. 2.5 in × 2.5 in (42 cm²)
    three single swab sticks used sequentially: approx. 5.0 in × 5.0 in (150 cm²)
tear pouch at side notch to reveal applicator handles. Do not touch applicator tip.
place foam flat side down on treatment area.
completely wet the treatment area with antiseptic.
 dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes; use applicator within 2 minutes from opening.
 moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes; use applicator within 2 minutes from opening.
discard the applicator after a single use along with any unused portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

Other information:

 Store at room temperature  Avoid freezing and excessive heat

Inactive ingredients:

Alkyl glucoside, Citric acid, Glycerin, Nonoxynol-10, Hydroxyethyl cellulose, Potassium iodine, Sodium hydroxide, USP purified water.

Questions?

www.escbrands.com  call +1(888)-331-8332 (M-F 8 a.m.-5 p.m. EST)

SPL UNCLASSIFIED SECTION

Patient Preoperative Skin Preparation

Not made with natural rubber latex

Do Not Reuse

Professional Use Only
External Use Only

Pharma Care One Step

Single swabstick applicators

DISTRIBUTED BY: ESC BRANDS, LLC
1026 BLUE PRINCE ROAD, SUITE B
BLUEFIELD, WV 24701 USA

POVIDONE-IODINE SWABSTICK

STERILIZED USING IRRADIATION 

SINGLE USE ONLY 

FLAMMABLE

AVOID DIRECT SUNLIGHT

DO NOT USE IF PACKAGE OPENED OR DAMAGED 

info@escbrands.com

Packaging

INGREDIENTS AND APPEARANCE

PHARMA CARE PRO STERILE PREP SWABSTICK POVIDONE-IODINE 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71884-059
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-10 (UNII: K7O76887AP)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71884-059-01	50 in 1 BOX	11/01/2025
1		1 in 1 POUCH
1		2.5 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 71884-059-03	25 in 1 BOX	11/01/2025
2		3 in 1 POUCH
2		2 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	11/01/2025

Labeler - Enviro Specialty Chemicals Inc (202621850)