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NDC 63868-0153-43 Isopropyl Alcohol 924 mg/mL Details

Isopropyl Alcohol 924 mg/mL

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

Product Information

NDC	63868-0153
Product ID	63868-153_db4e6f97-06c6-49f0-b882-aae6602d785b
Associated GPIs	48300010000520
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	924
Active Ingredient Units	mg/mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	CDMA
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 63868-0153-43 (63868015343)

Pricing Information	N/A
NDC Package Code	63868-153-43
Billing NDC	63868015343
Package	473 mL in 1 BOTTLE, PLASTIC (63868-153-43)
Marketing Start Date	2019-03-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eba136a7-4976-48ab-9a75-befb7e3a9999 Details

Active ingredients

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 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 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
will product serious gastric disturbances if taken internally

Inactive ingredients

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

ADVERSE REACTIONS SECTION

Distributed by C.D.M.A, Inc

4.157 W 9 Mile Rd, Novi, MI 48375

www.qualitychoice.com Questions: 800-935-2362

principal display panel

QUALITY

CHOICE

70%

Isopropyl

Alcohol

With Wintergreen

& Glycerin

First Aid Antiseptic

For Treatment of Minor

Cuts and Scranpes

WARNING

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

Use only in a well- ventiliated area: fumes can be harmful.

CAUTION: Do not point at self or others; product will squirt when squeezed.

16 fl oz ( 473 mL)

INGREDIENTS AND APPEARANCE

ISOPROPYL ALCOHOL

isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-153
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	924 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:63868-153-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/08/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part344	03/08/2019

Labeler - CDMA (011920774)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(63868-153)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(63868-153)

Revised: 4/2022

Document Id: db4e6f97-06c6-49f0-b882-aae6602d785b

Set id: eba136a7-4976-48ab-9a75-befb7e3a9999

Version: 8

Effective Time: 20220407