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NDC 41250-0697-06 Hand Sanitizer 558 mg/mL Details

Hand Sanitizer 558 mg/mL

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

Product Information

NDC	41250-0697
Product ID	41250-697_d4dc0896-2422-43fa-8745-745ebbbef2ea
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	558
Active Ingredient Units	mg/mL
Substance Name	ALCOHOL
Labeler Name	Meijer Distribution, 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 41250-0697-06 (41250069706)

Pricing Information	N/A
NDC Package Code	41250-697-06
Billing NDC	41250069706
Package	59 mL in 1 BOTTLE, PLASTIC (41250-697-06)
Marketing Start Date	2014-07-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fb785766-5dcb-4cc2-b680-45258daa639a Details

Active ingredient

Ethyl alcohol 62%

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 irritation and 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, carbomer, fragrance, hydroxypropyl methylcellulose, retinyl palmitate, tocopheryl acetate, mannitol, cellulose, ultramarines, yellow 6

Adverse reactions

Dist. By Meijer Distribution, Inc.

Grand Rapids, MI 49544

www.meijer.com

PRINCIPAL DISPLAY PANEL

Meijer

vanilla bean

Hand Sanitizer

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

HAND SANITIZER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-697
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	558 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
HYPROMELLOSES (UNII: 3NXW29V3WO)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
ULTRAMARINE BLUE (UNII: I39WR998BI)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-697-06	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/24/2014

Labeler - Meijer Distribution, Inc. (006959555)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(41250-697)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(41250-697)

Revised: 4/2022

Document Id: d4dc0896-2422-43fa-8745-745ebbbef2ea

Set id: fb785766-5dcb-4cc2-b680-45258daa639a

Version: 10

Effective Time: 20220422