BETADINE- povidone-iodine spray
Purdue Products LP

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.

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Betadine Spray

Povidone-iodine, 5%

Drug Facts

Active ingredient

Povidone-iodine, 5% (0.5% available iodine).

Purpose

Antiseptic

Uses

Patient pre-operative skin preparation

for preparation of the skin prior to surgery
helps reduce bacteria that potentially can cause skin infection

Warnings

For external use only

Do not use

in the eyes
If you are allergic to povidone-iodine or any other ingredients in this preparation

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 patient

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

hold container about 4-6 inches from skin
spray desired area n allow to dry
may be bandaged
replace cap after use

Other information

store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F). Do not freeze.

Inactive ingredients

citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, purified water

Dist. by: Purdue Products L.P., Stamford, CT 06901-3431
301821-0B

Betadine Spray
NDC 67618-148-03

BETADINE
povidone-iodine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67618-148
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	.05 mg in 1 mg

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67618-148-03	89 mg in 1 BOTTLE; Type 0: Not a Combination Product	04/15/1992	12/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/15/1992	12/31/2022

Labeler - Purdue Products LP (141916531)

Name	Address	ID/FEI	Business Operations
Establishment
Thatcher Company		041307356	MANUFACTURE(67618-148)

Revised: 9/2023

Document Id: c2083afd-9793-b01a-c41c-05ed2d44c269

Set id: 2f07daa4-86ee-4a2d-ae3a-c3a7b574ed10

Version: 2

Effective Time: 20230904

Purdue Products LP

Betadine Spray Povidone-iodine, 5%