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NDC 50804-0810-43 70% 70 mL/100mL Details

70% 70 mL/100mL

70% is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Perrigo Direct, Inc.. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	50804-0810
Product ID	50804-810_7aa546d4-ab35-464c-9eea-b2b7ba0dda5a
Associated GPIs	96201050002070
GCN Sequence Number	059624
GCN Sequence Number Description	isopropyl alcohol SPRAY 70 % TOPICAL
HIC3	W8E
HIC3 Description	ANTISEPTICS,GENERAL
GCN	25349
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	70
Active Ingredient Units	mL/100mL
Substance Name	ISOPROPYL ALCOHOL
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 50804-0810-43 (50804081043)

Pricing Information	N/A
NDC Package Code	50804-810-43
Billing NDC	50804081043
Package	473 mL in 1 BOTTLE, PLASTIC (50804-810-43)
Marketing Start Date	2010-04-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f953a249-07ad-40a1-8aea-b2d419fd3d4d Details

Active ingredient

Isopropyl alcohol 70%

Purpose

First aid antiseptic

Uses

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

for deep or puncture wounds, animal bites or serious burns

When using theis product

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

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
spray 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

Inactive ingredients

water

SPL UNCLASSIFIED SECTION

Distributed By: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

principal display panel

NDC 50804-810-43

GoodSense

70% Isopropyl Alcohol

First Aid Antisetpic
For Rubbing and Massaging

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

Use only in a well-ventilated area;

fumes can be harmful

CAUTION: Do not point at self or

others; product will squirt when squeezed.

16FL OZ (1PT) 473mL

INGREDIENTS AND APPEARANCE

70%

isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-810
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
Packaging
1	NDC:50804-810-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/08/2010
2	NDC:50804-810-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/08/2010
3	NDC:50804-810-72	295 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/08/2010
4	NDC:50804-810-08	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/08/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/08/2010

Labeler - Perrigo Direct, Inc. (076059836)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(50804-810)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(50804-810)

Revised: 10/2022

Document Id: 7aa546d4-ab35-464c-9eea-b2b7ba0dda5a

Set id: f953a249-07ad-40a1-8aea-b2d419fd3d4d

Version: 17

Effective Time: 20221027