L-Topical POVIDONE IODINE, 7.5% SCRUB

L-Topical POVIDONE IODINE, 7.5% SCRUB by

Drug Labeling and Warnings

L-Topical POVIDONE IODINE, 7.5% SCRUB by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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L-Topical POVIDONE IODINE, 7.5% SCRUB

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

L-TOPICAL POVIDONE IODINE, 7.5% SCRUB 
povidone iodine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73921-037
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73921-037-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/202102/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/202102/08/2023
Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)
Establishment
NameAddressID/FEIBusiness Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED860186917manufacture(73921-037)

Revised: 2/2023
 

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