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NDC 50804-0845-43 Isopropyl Alcohol 613 mg/mL Details

Isopropyl Alcohol 613 mg/mL

Isopropyl Alcohol 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	50804-0845
Product ID	50804-845_5ee13c70-d0b3-40dd-9238-12768e7b762c
Associated GPIs	96201050002070
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	Isopropyl Alcohol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	613
Active Ingredient Units	mg/mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Perrigo Direct, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part344
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50804-0845-43 (50804084543)

Pricing Information	N/A
NDC Package Code	50804-845-43
Billing NDC	50804084543
Package	473 mL in 1 BOTTLE, PLASTIC (50804-845-43)
Marketing Start Date	2011-04-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ec43a3f5-c5f3-439b-8764-ca92fefb45c9 Details

Active ingredient

Isopropyl alcohol 70%

Purpose

First aid antiseptic

Use

first aid to help prevent the rist 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 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 help 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 gettting into the eyes or on mucous membranes. Avoid inhaling this product.

Directions

clean the affected area
apply a small amount of this product on 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 substitute for grain or ethyl alcohol

inactive ingredients

blue 1, glycerin, methyl salicylate, water, yellow 5

SPL UNCLASSIFIED SECTION

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1888-593-0593

Pat. D675, 101

Principal Display Panel

NDC 50804-845-43

GOODSENSE

70%

Isopropyl

Alcohol

With Wintergreen and Glycerin

First Aid Antiseptic
For Rubbing and Massaging

100% SATISFACTION GUARANTEED

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.

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

ISOPROPYL ALCOHOL

isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-845
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	613 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL SALICYLATE (UNII: LAV5U5022Y)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-845-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/22/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part344	04/22/2011

Labeler - Perrigo Direct, Inc. (076059836)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(50804-845)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(50804-845)

Revised: 10/2022

Document Id: 5ee13c70-d0b3-40dd-9238-12768e7b762c

Set id: ec43a3f5-c5f3-439b-8764-ca92fefb45c9

Version: 17

Effective Time: 20221007