SPL v6
SPL
SPL Set ID 49db333e-36e1-1965-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2020-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (7.5 mg)
Inactive Ingredients
Hydroxyethyl Cellulose (5000 Mpa.s At 1%) Glycerin Monoethanolamine Lauryl Sulfate Water Sodium Phosphate, Dibasic, Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-03-03

Description

Antiseptic


Medication Information

Warnings and Precautions

For external use only

Do not• heat prior to application • use on individuals who are allergic or sensitive to iodine

Indications and Usage

-Washing whenever a germicidal soap is required

-Maximum degerming of hands

Dosage and Administration

A. For Preoperative Washing by Operating Personnel

1. Wet hands with water. Pour about 5 cc (1 teaspoonful) of PVP Scrub Solution on the palm of the hand and spread over both hands. Without adding more water, rub the Scrub thoroughly over all areas for about five minutes. Use brush if desired.

2. Clean thoroughly under fingernails. Add a litle water and develop copious suds. Rinse thoroughly under running water. Complete the wash by scrubbing with another 5 cc of PVP Scrub Solution in the same way.

B. For Preoperative Use on Patients

After the skin area is shaved, wet it with water. Apply PVP Scrub Solution (1 cc is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about five minutes. Rinse off by aid of sterile gauze saturated with water. The area may then be painted with PVP Scrub Solution and allowed to dry.

Description

Antiseptic

Section 50565-1

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

Section 51727-6

Disodium Phosphate, Glycerin, Hydroxy Ethyl Cellulose, Monoethanolamine, N-Dodecyl Sulfate, Purified Water

Section 51945-4

NDC# 68599-3501-1

NDC # 68599-3501-2

McKesson

PVP scrub Solution USP

7.5% Povidone Iodine

Antiseptic Bactericide / Virucidal Sudsing Skin Cleanser

Net Contents 16 fl oz (473 mL)

12 bottles per case

MFR# 037

Section 55105-1

Antiseptic

Section 55106-9

Povidone-Iodine, 7.5% (equivalent to 1% available iodine)

Section 60561-8

Do not store above 77°F (25ºC) - Do not store below 68°F (20°C)

Not made with natural rubber latex


Structured Label Content

Indications and Usage (34067-9)

-Washing whenever a germicidal soap is required

-Maximum degerming of hands

Dosage and Administration (34068-7)

A. For Preoperative Washing by Operating Personnel

1. Wet hands with water. Pour about 5 cc (1 teaspoonful) of PVP Scrub Solution on the palm of the hand and spread over both hands. Without adding more water, rub the Scrub thoroughly over all areas for about five minutes. Use brush if desired.

2. Clean thoroughly under fingernails. Add a litle water and develop copious suds. Rinse thoroughly under running water. Complete the wash by scrubbing with another 5 cc of PVP Scrub Solution in the same way.

B. For Preoperative Use on Patients

After the skin area is shaved, wet it with water. Apply PVP Scrub Solution (1 cc is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about five minutes. Rinse off by aid of sterile gauze saturated with water. The area may then be painted with PVP Scrub Solution and allowed to dry.

Warnings and Precautions (34071-1)

For external use only

Do not• heat prior to application • use on individuals who are allergic or sensitive to iodine

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Disodium Phosphate, Glycerin, Hydroxy Ethyl Cellulose, Monoethanolamine, N-Dodecyl Sulfate, Purified Water

Section 51945-4 (51945-4)

NDC# 68599-3501-1

NDC # 68599-3501-2

McKesson

PVP scrub Solution USP

7.5% Povidone Iodine

Antiseptic Bactericide / Virucidal Sudsing Skin Cleanser

Net Contents 16 fl oz (473 mL)

12 bottles per case

MFR# 037

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Povidone-Iodine, 7.5% (equivalent to 1% available iodine)

Section 60561-8 (60561-8)

Do not store above 77°F (25ºC) - Do not store below 68°F (20°C)

Not made with natural rubber latex


Advanced Ingredient Data


Raw Label Data

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