BETADINE- povidone-iodine solution

Betadine by

Drug Labeling and Warnings

Betadine by is a Otc medication manufactured, distributed, or labeled by Atlantis Consumer Healthcare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Povidone-iodine 10%

Purpose

Antiseptic

Use(s)

• for preparation of the skin prior to surgery
• first aid to help prevent 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 1 week unless directed by a doctor
• if you are allergic to iodine or other product ingredients
  

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious wounds
  

When using this product

• prolonged exposure may cause irritation or, rarely, severe skin reactions

Stop use and ask a doctor

• if condition persists or gets worse
  
• 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 (1-800-222-1222) right away.

Directions

• tear at notch
• remove applicator
• use only once

As a first aid antiseptic:

• clean affected area
• apply 1 to 3 times daily
• may be covered with a sterile bandage
  
• if bandaged, let dry first

For preoperative patient skin preparation:

• clean area
• apply to operative site using applicator then wait at least 30 seconds prior to surgery

Other Information

• store at room temperature 15°-30°C (59°-86°F)
• avoid excessive heat

Inactive Ingredients

citric acid, glycerin, polysorbate 80 (tween 80), sodium citrate USP, sodium phosphate dibasic, water

Questions

1-833-288-2684

Dist. by: Atlantis Consumer
Healthcare Inc.
Bridgewater, NJ 08807 USA

©2024 Atlantis Consumer
Healthcare Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 67618-190-01

BETADINE®
SOLUTION
Swabsticks
Povidone-iodine 10%

To Open Tear At Slit

Antiseptic Non-Sterile
Solution

Contains 1 Single-Use,
Disposable Swabstick

Do not use if package
is damaged or open.

Not Labeled for
Consumer Use

For Professional
and Hospital
Use Only

A1224

Dist. by: Atlantis Consumer
Healthcare Inc.
Bridgewater, NJ 08807 USA

See box for complete Drug Facts

©2024 Atlantis Consumer
Healthcare Inc.
Questions? 1-833-288-2684

NDC 67618-190-50

For Professional and Hospital Use Only

BETADINE®
SOLUTION
Swabsticks

Povidone-iodine 10%

Antiseptic Non-Sterile
Solution

50

Single-use, Disposable
Swabsticks
1 saturated swab per packet

LOT      LLLLLLLLLLLL

EXP      YYYY-MM-DD

NDC 67618-190-03

BETADINE®
SOLUTION
Swabsticks
Povidone-iodine 10%

To Open Tear At Slit

Antiseptic Non-Sterile
Solution

Contains 3 Single-Use,
Disposable Swabstick

Do not use if package is damaged or open.

For Professional and Hospital Use Only

Not Labeled for Consumer Use

See box for complete Drug Facts

Dist. by: Atlantis Consumer Healthcare Inc.
Bridgewater, NJ 08807 USA

A1224

©2024 Atlantis Consumer Healthcare Inc.
Questions? 1-833-288-2684

NDC 67618-190-25

For Professional and Hospital Use Only

BETADINE®
SOLUTION
Swabsticks

Povidone-iodine 10%

Antiseptic Non-Sterile
Solution

25

Single-use, Disposable
Swabsticks
3 saturated swabs per packet

LOT      LLLLLLLLLLLL

EXP      YYYY-MM-DD

INGREDIENTS AND APPEARANCE

BETADINE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-190
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Sodium Phosphate, Dibasic, Unspecified Form (UNII: GR686LBA74)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-190-01	1 in 1 POUCH	07/01/2025
1		1.9 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 67618-190-03	3 in 1 POUCH	07/01/2025
2		1.9 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC: 67618-190-50	50 in 1 BOX	07/01/2025
3		1 in 1 PACKET
3		1.9 mL in 1 APPLICATOR; Type 0: Not a Combination Product
4	NDC: 67618-190-25	25 in 1 BOX	07/01/2025
4		3 in 1 PACKET
4		1.9 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	07/01/2025

Labeler - Atlantis Consumer Healthcare, Inc. (118983925)

Registrant - Atlantis Consumer Healthcare, Inc. (118983925)