Search by Drug Name or NDC

NDC 50804-0088-10 Iodine 470; 20; 20.4 mg/mL; mg/mL; mg/mL Details

Iodine 470; 20; 20.4 mg/mL; mg/mL; mg/mL

Iodine is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Perrigo Direct, Inc.. The primary component is ALCOHOL; IODINE; SODIUM IODIDE.

Product Information

NDC	50804-0088
Product ID	50804-088_51d752c5-0390-4a5f-872f-70a32bbff593
Associated GPIs	92200020001510
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	Iodine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Iodine
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	470; 20; 20.4
Active Ingredient Units	mg/mL; mg/mL; mg/mL
Substance Name	ALCOHOL; IODINE; SODIUM IODIDE
Labeler Name	Perrigo Direct, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50804-0088-10 (50804008810)

Pricing Information	N/A
NDC Package Code	50804-088-10
Billing NDC	50804008810
Package	30 mL in 1 BOTTLE, PLASTIC (50804-088-10)
Marketing Start Date	2008-11-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3b424440-5bb7-4207-9884-1461a54fbe0b Details

Active Ingredient

Iodine 2%

Purpose

First aid antiseptic

Use

First aid to help prevent skin infection in

minor cuts
scrapes
burns

Warnings

For external use only

Ask a doctor before use

if you have deep or puncture wounds, animal bites or serious burns.

When using this product

do not use in eyes or apply over large areas of the body
do not use longer than 1 week unless directed by a doctor

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 on the area 1 to 3 times daily
may be covered with a sterile bandage
if bandaged, let dry first

Other information

product will stain skin and clothing

Inactive ingredients

alcohol (47% v/v), purified water, sodium iodide

SPL UNCLASSIFIED SECTION

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDriect.com 1-888-593-0593

Principal Display Panel

NDC 50804-088-10

GoodSense

Iodine

Tincture U.S.P.

First Aid Antiseptic

For external use only

CAUTION: POISON

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

IODINE

iodine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-088
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	20 mg in 1 mL
SODIUM IODIDE (UNII: F5WR8N145C) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	20.4 mg in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	470 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-088-10	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/08/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/08/2008

Labeler - Perrigo Direct, Inc. (076059836)

Registrant - Vi-Jon, LLC (088520668)

Name	Address	ID/FEI	Business Operations
Establishment
Pharma Nobis, LLC		118564114	manufacture(50804-088)

Revised: 11/2022

Document Id: 51d752c5-0390-4a5f-872f-70a32bbff593

Set id: 3b424440-5bb7-4207-9884-1461a54fbe0b

Version: 9

Effective Time: 20221118