QUALITY CHOICE POVIDONE IODINE- povidone iodine 10% liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)

Available from:

Chain Drug Market Association

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic First aid antiseptic to prevent infection in minor cuts and burns. - deep punture wounds - animal bites - serious burns - the condition persists or gets worse - irritation and redness develop and persits for more than 72 hours

Authorization status:

OTC monograph not final

Summary of Product characteristics

QUALITY CHOICE POVIDONE IODINE- POVIDONE IODINE 10% LIQUID
CHAIN DRUG MARKET ASSOCIATION
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QUALITY CHOICE POVIDONE IODINE
Drug Facts
ACTIVE INGREDIENT
Povidone-Iodine 10%
(Equivalent to 1% titrable iodine)
PURPOSE
Antiseptic
USE
First aid antiseptic to prevent infection in minor cuts and burns.
WARNINGS
For External Use Only
ASK A DOCTOR BEFORE USE IF YOU HAVE
deep punture wounds
animal bites
serious burns
STOP USE AND CONSULT A DOCTOR IF
the condition persists or gets worse
irritation and redness develop and persits for more than 72 hours
WHEN USING THIS PRODUCT DO NOT
use in eyes
use on individuals who are allergic or sensitive to iodine or use for
longer thn 1 week
unless directed by a doctor
apply over large areas of the body
KEEP OUT OF REACH OF CHILDREN.
In case of accidental ingestion, seek professional assistance or
contact a Poison Control
Center immediately.
DIRECTIONS
For preparation of the skin prior to surgery. Apply to the operative
site prior to surgery.
As a first aid antiseptic. Clean the affected area. Apply a small
amount on the area 1 to 3
times daily. May be covered with sterile bandage. If badaged, let it
dry first.
INACTIVE INGREDIENTS
Citric Acid, Disodium Phosphate, Glycerin, nonoxynol-9. Sodium
Hydroxide and Purified
Water.
PRINCIPAL DISPLAY PANEL
QUALITY CHOICE POVIDONE IODINE
povidone iodine 10% liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:63868-230
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
Chain Drug Market Association
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
100 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:63868-
230-08
237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
12/12/2017
MA