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NDC 70000-0541-01 Isopropyl Rubbing Alcohol 70 mL/100mL Details

Isopropyl Rubbing Alcohol 70 mL/100mL

Isopropyl Rubbing Alcohol is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, 110 dba Leader. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	70000-0541
Product ID	70000-0541_69abadb9-5b5f-4386-8353-3c085c704780
Associated GPIs	96201050102070
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	Isopropyl Rubbing Alcohol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Cardinal Health, 110 dba Leader
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70000-0541-01 (70000054101)

Pricing Information	N/A
NDC Package Code	70000-0541-1
Billing NDC	70000054101
Package	236 mL in 1 BOTTLE, PUMP (70000-0541-1)
Marketing Start Date	2015-05-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 08f52962-fe0e-4a2b-9860-ff7db999b40b 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. If taken internally serious gastric disturbances will result.

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

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

SPL UNCLASSIFIED SECTION

Caution - Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

Directions

clean the affected area
pump a small amount of product on a clean pad and apply to the 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 substite for grain or ethyl alcohol

Inactive ingredient

water

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

100% money back guarantee. Return to place of purchase if not satisfied.

PRINCIPAL DISPLAY PANEL

NDC 70000-0541-1

LEADER 70% Isopropyl Rubbing Alcohol

First Aid Antiseptic

For treatment of minor cuts and scrapes

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

Use only in a well-ventilated area:

fumes may be harmful

100% money back guarantee

8 FL OZ 236 mL

INGREDIENTS AND APPEARANCE

ISOPROPYL RUBBING ALCOHOL

isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0541
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0541-1	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/09/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/09/2012

Labeler - Cardinal Health, 110 dba Leader (063997360)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(70000-0541)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(70000-0541)

Revised: 6/2022

Document Id: 69abadb9-5b5f-4386-8353-3c085c704780

Set id: 08f52962-fe0e-4a2b-9860-ff7db999b40b

Version: 20

Effective Time: 20220629

Search by Drug Name or NDC

NDC 70000-0541-01 Isopropyl Rubbing Alcohol 70 mL/100mL Details

Isopropyl Rubbing Alcohol 70 mL/100mL

Product Information

Package

Package Images

NDC 70000-0541-01 (70000054101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 08f52962-fe0e-4a2b-9860-ff7db999b40b Details

Active Ingredient

Purpose

Use

Warnings

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredient

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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