Search by Drug Name or NDC

NDC 30142-0589-34 Hand Sanitizer 545 mg/mL Details

Hand Sanitizer 545 mg/mL

Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Krogers. The primary component is ALCOHOL.

Product Information

NDC	30142-0589
Product ID	30142-589_9b6db68b-666f-4714-a05d-ce7529a51109
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	Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	545
Active Ingredient Units	mg/mL
Substance Name	ALCOHOL
Labeler Name	Krogers
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 30142-0589-34 (30142058934)

Pricing Information	N/A
NDC Package Code	30142-589-34
Billing NDC	30142058934
Package	236 mL in 1 BOTTLE, PLASTIC (30142-589-34)
Marketing Start Date	2017-01-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d8901ee1-9ff9-4d78-93e6-2ffd55026e2b Details

Active ingredient

Ethyl alcohol 63%

Purpose

Antiseptic

Uses

to decrease bacteria on the skin that could cause disease
recommended for repeated use

Warnings

For external use only: hands

Flammable

Keep away from fire and flame

when using this product

keep out of eyes. Incase of contact with eyes, flush thoroughly with water
avoid contact with broken skin
do not inhale or ingest

Stop use and ask a doctor

if skin irritation or redness develops
condition persists for more than 72 hours

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

wet hands thoroughly with product and allow to dry without wiping
for children under 6, use only under adult supervision
not recommended for infants

Other information

do not store above 105⁰F
may discolor some fabrics
harmful to wood finishes and plastics

Inactive ingredients

water, glycerin, tocopheryl acetate, retinyl palmitate, carbomer, fragrance, benzophenone-4, mannitol, cellulose, hydroxypropyl methylcellulose, ultamarines

claims

Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 seconds.

adverse reactions section

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

QUALITY GUARANTEE

800-632-6900 www.kroger.com

Principal display panel

Kroger

COCONUT WATER

SCENTED

HAND SANITIZER

KILLS 99.99% OF GERMS

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

HAND SANITIZER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-589
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	545 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SULISOBENZONE (UNII: 1W6L629B4K)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ULTRAMARINE BLUE (UNII: I39WR998BI)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:30142-589-16	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/10/2017
2	NDC:30142-589-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/10/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/10/2017

Labeler - Krogers (006999528)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(30142-589)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(30142-589)

Revised: 6/2022

Document Id: 9b6db68b-666f-4714-a05d-ce7529a51109

Set id: d8901ee1-9ff9-4d78-93e6-2ffd55026e2b

Version: 12

Effective Time: 20220603