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NDC 37205-0976-43 Ethyl Rubbing Alcohol 0.7 L/100L Details

Ethyl Rubbing Alcohol 0.7 L/100L

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

Product Information

NDC	37205-0976
Product ID	37205-976_c96e5c61-23b6-4c81-a291-bb2c5248afcf
Associated GPIs	96201020202070
GCN Sequence Number	045156
GCN Sequence Number Description	ethyl alcohol SOLUTION 70 % TOPICAL
HIC3	Q5B
HIC3 Description	TOPICAL PREPARATIONS,ANTIBACTERIALS
GCN	12232
HICL Sequence Number	001681
HICL Sequence Number Description	ETHYL ALCOHOL
Brand/Generic	Generic
Proprietary Name	Ethyl 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	0.7
Active Ingredient Units	L/100L
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Cardinal Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2022-12-31

Package

Package Images

NDC 37205-0976-43 (37205097643)

Pricing Information	N/A
NDC Package Code	37205-976-43
Billing NDC	37205097643
Package	.473 L in 1 BOTTLE, PLASTIC (37205-976-43)
Marketing Start Date	2012-05-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ff6b5d48-471d-4c4e-9f55-fb3816641202 Details

Active ingredient

Ethyl 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 help or contact a Poison Control Center right away.

For Rubbing & Massaging:

Caution - Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or mucous membranes.

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

will product serious gastric disturbances if taken internally

Inactive ingredients

acetone, denatonium benzoate, methyl isobutyl ketone, water

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

CIN 2369411 www.myleader.com 1-800-200-6313

Principal Display Panel

NDC 37205-979-43

LEADER

Ethyl Rubbing Alcohol

70% by volume

First Aid Antiseptic

For Rubbing and Massaging

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

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

SATISFACTION GUARANTEED

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

ETHYL RUBBING ALCOHOL

isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-976
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 L in 100 L

Ingredient Name	Strength
Inactive Ingredients
ACETONE (UNII: 1364PS73AF)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
METHYL ISOBUTYL KETONE (UNII: U5T7B88CNP)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-976-43	.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/10/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/10/2012

Labeler - Cardinal Health (097537435)

Registrant - Vi-Jon Inc (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, Inc		790752542	manufacture(37205-976)

Revised: 11/2018

Document Id: c96e5c61-23b6-4c81-a291-bb2c5248afcf

Set id: ff6b5d48-471d-4c4e-9f55-fb3816641202

Version: 5

Effective Time: 20181129