Label: L-TOPICAL POVIDONE IODINE, 7.5% SCRUB- povidone iodine liquid
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- NDC Code(s): 73921-037-04
- Packager: GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated March 30, 2021
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- DRUG FACTS
- Active ingredient
- Purpose
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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 patientStop use and ask a doctor
• If irritation and redness develop • In rare instances of local irritation or sensitivity -
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 ScrubB. 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 towelC. 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
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INGREDIENTS AND APPEARANCE
L-TOPICAL POVIDONE IODINE, 7.5% SCRUB
povidone iodine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73921-037 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0) NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73921-037-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2021 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 Business Operations GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED 860186917 manufacture(73921-037)
