Pharma Care Pro 

Pharma Care Pro 
SPL v1
SPL
SPL Set ID 915a96fe-e807-4697-9d50-b6b8af085827
Route
TOPICAL
Published
Effective Date 2025-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
C12-20 Alkyl Glucoside Citric Acid Monohydrate Glycerin Nonoxynol-10 Hydroxyethyl Cellulose, Unspecified Potassium Iodide Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

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

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

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

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.

Section 42229-5

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 

[email protected]

Section 50565-1

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

Purposes

Antiseptic

Packaging

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.

Questions?

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

Drug Facts:

Active Ingredients

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

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.


Structured Label Content

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.

Section 42229-5 (42229-5)

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 

[email protected]

Section 50565-1 (50565-1)

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

Purposes

Antiseptic

Packaging

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.

Questions?

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

Drug Facts:

Active Ingredients (Active ingredients)

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

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: (Other information:)

• Store at room temperature • Avoid freezing and excessive heat

Inactive Ingredients: (Inactive ingredients:)

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


Advanced Ingredient Data


Raw Label Data

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