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NDC 00574-0067-16 70% 500 mg/mL Details

70% 500 mg/mL

70% is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Paddock Laboratories LLC. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	00574-0067
Product ID	0574-0067_9f5d1cea-be7a-440b-afc9-2dd5c3021634
Associated GPIs	96201050002070
GCN Sequence Number	008548
GCN Sequence Number Description	isopropyl alcohol SOLUTION 70 % MISCELL
HIC3	U6H
HIC3 Description	SOLVENTS
GCN	36771
HICL Sequence Number	003803
HICL Sequence Number Description	ISOPROPYL ALCOHOL
Brand/Generic	Generic
Proprietary Name	70%
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	500
Active Ingredient Units	mg/mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Paddock Laboratories LLC
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 00574-0067-16 (00574006716)

Pricing Information	N/A
NDC Package Code	0574-0067-16
Billing NDC	00574006716
Package	473 mL in 1 BOTTLE, PLASTIC (0574-0067-16)
Marketing Start Date	2014-04-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 24083a34-813b-4870-a060-ede62d777329 Details

Active ingredient

Isopropyl alcohol 70%

Purpose

First Aid Antiseptic

Use

First aid to help prevent the risk of infection in:

•minor cuts •scrapes •burns

Warnings

For external use only

Flammable

keep away from fire or flame, heat, spark, electrical

Ask a Doctor before use

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

When using this product

do not get into eyes
do not 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 hep or contact a Poison Control Center right away

Directions

clean the affected area
apply a small amount of this product on the affected area 1 to 3 times daily
may be covered with a sterile bandage
if bandaged, let dry first

Other information

•does not contain, nor is intended as a substitute for grain or ethyl alcohol

•will produce serious gastric disturbances if taken internally

Inactive ingredients

water

SPL UNCLASSIFIED SECTION

Distributed By Perrigo

Minneapolis, MN 55427

principal display panel

Perrigo

NDC 0574-0067-16

Isopropyl Rubbing Alcohol 70% USP

First Aid Antiseptic

WARNING FLAMMABLE Keep away from heat, spark, electrical, fire or flame

Use only in a well-ventilated area; fumes may be harmful

CAUTION: Do not point at self or others; product will squirt when squeezed

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

70%

isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0574-0067
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	500 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:0574-0067-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/14/2014

Labeler - Paddock Laboratories LLC (967694121)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(0574-0067)

Revised: 8/2022

Document Id: 9f5d1cea-be7a-440b-afc9-2dd5c3021634

Set id: 24083a34-813b-4870-a060-ede62d777329

Version: 15

Effective Time: 20220825