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NDC 36800-0011-34 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 Topco Associates LLC. The primary component is POVIDONE-IODINE.

Product Information

NDC	36800-0011
Product ID	36800-011_e58c798d-f969-48e7-861d-6908fbeecb9e
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	Topco Associates LLC
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 36800-0011-34 (36800001134)

Pricing Information	N/A
NDC Package Code	36800-011-34
Billing NDC	36800001134
Package	237 mL in 1 BOTTLE, PLASTIC (36800-011-34)
Marketing Start Date	2004-07-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e258fbd2-f1dd-4ba0-ac9b-64246f2db50b Details

Active ingredient

Povidone-iodine, 10%

(1% available iodine)

Purpose

First aid antiseptic

uses

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 cae of deep or puncture counds, 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 inforamation

 store between 15º-30ºC (59º-86ºF)

inactive ingredents

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

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

TOPCO VIJA0622

QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

*This product is not manufactured or distributed by Avrio Health L.P., distributor of Betadine Antiseptic 10% Povidone-Iodine First Aid Antiseptic.

Quality Guaranteed

This TopCare product is laboratory tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

Scan here for more information or call 1-888-423-0139

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TopCare health

Compare to Betadine Active Ingredient

Povidone-Iodine Solution, 10%

FIRST AID ANTISEPTIC

Kills germs in minor cuts, scrapes, and burns
Used by Hospitals, Doctors & Nurses
Water Soluble

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:36800-011
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:36800-011-34	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/29/2004

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/29/2004

Labeler - Topco Associates LLC (006935977)

Registrant - Vi Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		790752542	manufacture(36800-011)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		088520668	manufacture(36800-011)

Revised: 8/2022

Document Id: e58c798d-f969-48e7-861d-6908fbeecb9e

Set id: e258fbd2-f1dd-4ba0-ac9b-64246f2db50b

Version: 19

Effective Time: 20220801