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NDC 49035-0050-34 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 Wal-Mart Stores, Inc.. The primary component is POVIDONE-IODINE.

Product Information

NDC	49035-0050
Product ID	49035-050_84183e64-b074-4eef-91fb-a2cdf033f904
Associated GPIs	92200040002015
GCN Sequence Number	007233
GCN Sequence Number Description	povidone-iodine SOLUTION 10 % TOPICAL
HIC3	Q5B
HIC3 Description	TOPICAL PREPARATIONS,ANTIBACTERIALS
GCN	45334
HICL Sequence Number	004265
HICL Sequence Number Description	POVIDONE-IODINE
Brand/Generic	Generic
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	Wal-Mart Stores, Inc.
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 49035-0050-34 (49035005034)

Pricing Information	N/A
NDC Package Code	49035-050-34
Billing NDC	49035005034
Package	237 mL in 1 BOTTLE, PLASTIC (49035-050-34)
Marketing Start Date	2010-02-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c8fa5ed3-0497-4a23-934b-c72ff02c94ae Details

Active ingredient

Povidone-iodine, 10%

(equivalent to 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 if

condition persists or gets worse

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 15º-30ºC (59º-86ºF)

Inactive ingredients

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

Questions

call: 1-888-287-1915

Satisfaction guaranteed

for questions or comments please call 1-888-287-1915

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Purdure products, LP, Owner of the registered trademark Betadine

Distributed by: Wal-Mart Stores, Inc.

Bentonville, AR 72716 Wal-Mart Stores, Inc

principal display panel

NDC 49035-050-34

equate

*Compare to Betadine Solution Active Ingredient

First Aid Antiseptic

10% Povidone-Iodine Topical Solution

Kills Germs Promptly in Minor Cuts, Scrapes, and Burns

NET 8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

FIRST AID ANTISEPTIC

povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-050
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:49035-050-34	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/03/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/03/2010

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Vi Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		790752542	manufacture(49035-050)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		088520668	manufacture(49035-050)

Revised: 4/2022

Document Id: 84183e64-b074-4eef-91fb-a2cdf033f904

Set id: c8fa5ed3-0497-4a23-934b-c72ff02c94ae

Version: 12

Effective Time: 20220414