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NDC 00363-0777-34 First Aid Antiseptic 10 mg/mL Details

First Aid Antiseptic 10 mg/mL

First Aid Antiseptic is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. The primary component is POVIDONE-IODINE.

Product Information

NDC	00363-0777
Product ID	0363-0777_4d7293cd-9f80-444e-af91-483e8998ab79
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	First Aid Antiseptic
Proprietary Name Suffix	n/a
Non-Proprietary Name	POVIDONE-IODINE
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	POVIDONE-IODINE
Labeler Name	Walgreens
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-0777-34 (00363077734)

Pricing Information	N/A
NDC Package Code	0363-0777-34
Billing NDC	00363077734
Package	236 mL in 1 BOTTLE, PLASTIC (0363-0777-34)
Marketing Start Date	2016-09-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b1c71ff1-8ffa-46df-9b43-86ed062c3a98 Details

Active ingredient

Povidone-iodine, 10%

(1% available iodine)

Purpose

First aid antiseptic

Use

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 apply over large areas of the body
longer than 1 week unless directed by a doctor

Ask a doctor before use

in case of deep or puncture wounds, animal bites, or 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 right away.

Directions

clean the affected area
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

Other information

store between 15°-30° C (59°-86F)

inactive ingredients

C12-13 Pareth-9, citric acid, disodium phosphate, glycerin, sodium hydroxide, water

Questions?

1-888-593-0593

SPL UNCLASSIFIED SECTION

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

This product or is not manufactured or distributed by Purdue Products L.P., distributor of Betadine First Aid Solution 10% Povidone-iodine Topical Solution

050.002/050AE

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com

2017 Walgreen C0.

principal display panel

Walgreens

Compare to Betadine Solution active ingredient

10% Povidone-Iodine Solution

FIRST AID ANTISEPTIC

Helps kill germs & preven infection from minor burns, cuts and scrapes

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

FIRST AID ANTISEPTIC

povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0777
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
C12-13 PARETH-9 (UNII: 9BXD858P37)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0777-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/02/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/02/2016

Labeler - Walgreens (008965063)

Registrant - Vi Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		790752542	manufacture(0363-0777)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		088520668	manufacture(0363-0777)

Revised: 3/2022

Document Id: 4d7293cd-9f80-444e-af91-483e8998ab79

Set id: b1c71ff1-8ffa-46df-9b43-86ed062c3a98

Version: 9

Effective Time: 20220307