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NDC 41250-0998-16 Glazed Pear 62 mg/mL Details

Glazed Pear 62 mg/mL

Glazed Pear is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distributioin, Inc. The primary component is ALCOHOL.

Product Information

NDC	41250-0998
Product ID	41250-998_1fbc3cca-a44e-44f9-9c10-5ba4f6827eee
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	Glazed Pear
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	62
Active Ingredient Units	mg/mL
Substance Name	ALCOHOL
Labeler Name	Meijer Distributioin, 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 41250-0998-16 (41250099816)

Pricing Information	N/A
NDC Package Code	41250-998-16
Billing NDC	41250099816
Package	59 mL in 1 BOTTLE, PLASTIC (41250-998-16)
Marketing Start Date	2016-08-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3aca6514-0844-4b82-867f-87820f0aef87 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 or flame.

When using this product

keep out of eyes. In case 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 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 hand 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 105°F
may discolor some fabrics
harmful to wood finishes and plastics

Inactive ingredients

water, glycerin, carbomer, fragrance, yellow 5, blue 1

disclamer

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

Adverse reactions

DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 469544

www. meijer.com

Questions 1-888-593-0593

principal display panel

meijer

Hand

Sanitizer

Glazed Pear

Kills 99.99% of germs

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

GLAZED PEAR

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-998
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-998-16	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/24/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/24/2016

Labeler - Meijer Distributioin, Inc (006959555)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(41250-998)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(41250-998)

Revised: 3/2022

Document Id: 1fbc3cca-a44e-44f9-9c10-5ba4f6827eee

Set id: 3aca6514-0844-4b82-867f-87820f0aef87

Version: 10

Effective Time: 20220310