L-Topical POVIDONE IODINE, 7.5% SCRUB

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:47:02

Label at a glance#

ProductL-Topical POVIDONE IODINE, 7.5% SCRUB
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Indications and uses

• For preparation of the skin prior to surgery • Helps to reduce bacteria that potentially can cause skin infection • For handwashing to reduce bacteria on the skin • Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Dosage and administration

A. Surgical hand scrub: • Wet hands with water • Spread about 5 cc (1 teaspoonful) of Scrub over both hands and forearms • Without adding more water, scrub thoroughly for 2 1/2 to 3 minutes • Use a sponge if desired. Clean thoroughly under fingernails. • Add a little water and develop copious suds. Rinse thoroughly under running water. • Repeat the entire procedure using another 5 cc of Scrub B. Antiseptic hand wa...

Storage and handling

• Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) • Store in original container

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine, 7.5% (0.75% available iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• For preparation of the skin prior to surgery • Helps to reduce bacteria that potentially can cause skin infection • For handwashing to reduce bacteria on the skin • Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

WARNINGS SECTION

For external use only

Do not use this product in the eyes

When using this product
•
Prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions • In pre-operative prepping avoid “pooling” beneath the patient

Stop use and ask a doctor
• If irritation and redness develop • In rare instances of local irritation or sensitivity

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

A. Surgical hand scrub:
• Wet hands with water • Spread about 5 cc (1 teaspoonful) of Scrub over both hands and forearms • Without adding more water, scrub thoroughly for 2 1/2 to 3 minutes • Use a sponge if desired. Clean thoroughly under fingernails. • Add a little water and develop copious suds. Rinse thoroughly under running water. • Repeat the entire procedure using another 5 cc of Scrub

B. Antiseptic hand wash:
• Wet hands with water and pour about 5 cc of Scrub on hands • Rub hands vigorously together for at least 15 seconds, covering all surfaces • Rinse and dry with a disposable towel

C. Patient pre-operative skin preparation:
• Single use only • Wet skin with water • Apply Scrub (1 cc is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about 5 minutes • Rinse off using sterile gauze saturated with water • The area may then be painted with BETADINE Solution and allowed to dry

Other information

STORAGE AND HANDLING SECTION

• Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• Store in original container

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ammonium nonoxynol-4 sulfate, nonoxynol-9, purified water, sodium hydroxide

Questions?

OTC - QUESTIONS SECTION

Call toll-free 1-800-572-6632, Weekdays 7:00 AM - 5.30 PM EST.

SPL UNCLASSIFIED SECTION

√ Antiseptic Non-Sterile Scrub

Manufactured by:

Global pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

povidone37-1povidone37-1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-037-042023-02-08C16284748780-1f386c649-a253-0266-e053-dadaa90a7c1aL-Topical POVIDONE IODINE, 7.5% SCRUB
73921-037-042023-01-30C16284748780-1f386c649-a253-0266-e053-dadaa90a7c1aL-Topical POVIDONE IODINE, 7.5% SCRUB

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-03773921-037-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f42ad3c6-61cf-93da-e053-2a95a90a9fdcab3eea55-4e13-4f60-9db2-0380beb0f18c2023-02-08WarningsExact identifier
spl set id: ab3eea55-4e13-4f60-9db2-0380beb0f18c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.