OTC Medication Information: L-Topical POVIDONE IODINE, 7.5% SCRUB

L-TOPICAL POVIDONE IODINE, 7.5% SCRUB- povidone-iodine liquid
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

Active ingredient

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

Purpose

Antiseptic

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

Warnings

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

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

Directions

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

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

Inactive ingredients

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

Questions?

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

√ 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

povidone37-1
(click image for full-size original)

L-TOPICAL POVIDONE IODINE, 7.5% SCRUB
povidone iodine liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73921-037
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (IODINE) IODINE 75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
AMMONIUM NONOXYNOL-4 SULFATE
NONOXYNOL-9
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73921-037-04 118 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/01/2021
Labeler — GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)
Establishment
Name Address ID/FEI Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED 860186917 manufacture (73921-037)

Revised: 03/2021 GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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