Search by Drug Name or NDC

NDC 36800-0804-43 Isopropyl Alcohol 0.91 mg/mL Details

Isopropyl Alcohol 0.91 mg/mL

Isopropyl Alcohol is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by TopCo Assoc LLC. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	36800-0804
Product ID	36800-804_7a07681f-a683-475b-849d-39398c6f4e1b
Associated GPIs
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	0.91
Active Ingredient Units	mg/mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	TopCo Assoc 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 36800-0804-43 (36800080443)

Pricing Information	N/A
NDC Package Code	36800-804-43
Billing NDC	36800080443
Package	.473 mL in 1 BOTTLE, PLASTIC (36800-804-43)
Marketing Start Date	1991-03-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ad1ef2ea-bfc3-4a8a-acd2-55e7f52813d4 Details

Active Ingredient

Isopropyl alcohol 91%

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

for 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 getting 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

water

SPL UNCLASSIFIED SECTION

DIST. BY TOPCO ASSOC LLC ELK GROOVE VILLAGE, IL 60077

QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrands.com

principal display panel

TopCare

health

91%

Isopropyl

Alcohol

FIRST AID ANTISEPTIC

Helps Prevent the Risk of Infection in:

Minor Cuts
Minor Scrapes
Minor Burns

OUR PHARMACISTS RECOMMEND

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 whe squeezed.

Visit here for more information:

http://topbrands.com/48zrdj

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:36800-804
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	.91 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:36800-804-43	.473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/1991

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/15/1991

Labeler - TopCo Assoc LLC (006935977)

Registrant - Vi-Jon Inc, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, Inc, LLC		790752542	manufacture(36800-804)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, Inc, LLC		088520668	manufacture(36800-804)

Revised: 8/2022

Document Id: 7a07681f-a683-475b-849d-39398c6f4e1b

Set id: ad1ef2ea-bfc3-4a8a-acd2-55e7f52813d4

Version: 13

Effective Time: 20220808