Active Ingredient

Povidone-Iodine USP 10% w/v (9.85% w/w)

Purpose

First Aid Antiseptic

Use(s)

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

Warnings

For External Use Only

Do not use

• In the eyes or over large areas of the body

• Longer than one week unless directed by a doctor

Ask a doctor before use if you have

• Deep or puncture wounds

• Animal bites

• Serious burns

Stop use and ask a doctor if

• Condition persists or gets worse

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Tear at notch
Remove prep pad
Apply a small amount of this product on the area 1 to 3 times daily.
May be covered with a sterile bandage
If bandaged, let dry first
Use only once

Other Information

Store at room temperature 15º-30ºC (59º-86ºF)
Flammable. Keep away from fire or flame

Inactive Ingredients

Anhydrous Citric Acid, Glycerin, Polysorbate 80, Sodium Citrate, Sodium Phosphate Dibasic, Water

Label

Povidone-Iodine Prep Pads

Label

1108 BX MASTER Povidon Iodine Prep Pad

Label 1108UB-10

1108UB-10_BX_MASTER 1108UB-10

POVIDONE IODINE PREP PAD
antiseptic swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67777-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67777-002-01	1000 in 1 CASE	12/17/2018
1	NDC:67777-002-02	100 in 1 BOX
1		0.3 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC:67777-002-03	1000 in 1 CASE	12/17/2018
2	NDC:67777-002-04	10 in 1 BOX
2		0.3 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M003	12/17/2018

Labeler - Dynarex Corporation (008124539)

1108 Povidone Iodine Prep Pad NDC 67777-002-01 1108UB-10 Povidone Iodine Prep Pad NDC 67777-002-03

Active Ingredient

Purpose

Use(s)

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children

Directions

Other Information

Inactive Ingredients

Label

Label

Label 1108UB-10

1108 Povidone Iodine Prep Pad NDC 67777-002-01
1108UB-10 Povidone Iodine Prep Pad NDC 67777-002-03