POVIDONE-IODINE PREP PAD- povidone-iodine swab

Povidone-iodine prep pad by

Drug Labeling and Warnings

Povidone-iodine prep pad by is a Otc medication manufactured, distributed, or labeled by Guangdong Comfort Medical Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Purpose

Antiseptic

CAUTION: Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

Indications and usage section

First aid to help prevent infection in minor cuts, scrapes, and burns

WARNINGS

For external use only. Flammable, keep away from fire or flame.

Do notuse

﹒in the eyes or apply over large areas of the body.

﹒on individuals who are allergic or sensitive to iodine.

Stop use

If irritation, redness or other symptoms develop.

Ask a doctor

If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns.

Directions

Apply product on the area 1-3 times daily and discard.

INACTIVE INGREDIENT

ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

DRUG FACTS

Active ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)

Purpose

Antiseptic

Use

First aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

For external use only. Flammable, keep away from fire or flame.

Do notuse

﹒in the eyes or apply over large areas of the body.

﹒on individuals who are allergic or sensitive to iodine.

Stop use

If irritation, redness or other symptoms develop.

Ask a doctor

If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns.

CAUTION: Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply product on the area 1-3 times daily and discard.

Other information: Store at room temperature.

Inactive ingredients

ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE PREP PAD 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71584-0104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	9.43 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71584-0104-1	9.43 g in 1 POUCH; Type 0: Not a Combination Product	07/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	07/17/2017

Labeler - Guangdong Comfort Medical Products Co., Ltd. (544507534)

Registrant - Guangdong Comfort Medical Products Co., Ltd. (544507534)