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NDC 62172-0118-13 HAND SANITIZER 62 mL/100mL Details

HAND SANITIZER 62 mL/100mL

HAND SANITIZER is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by DIVERSIFIED MANUFACTURING CORP. The primary component is ALCOHOL.

Product Information

NDC	62172-0118
Product ID	62172-118_d60ee0ff-2558-375e-e053-2a95a90aa97a
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	62
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	DIVERSIFIED MANUFACTURING CORP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 62172-0118-13 (62172011813)

Pricing Information	N/A
NDC Package Code	62172-118-13
Billing NDC	62172011813
Package	500 mL in 1 BOTTLE (62172-118-13)
Marketing Start Date	2020-06-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a7e86ca4-669c-4cd3-b080-85e610b87cdf Details

ACTIVE INGREDIENT

ETHYL ALCOHOL (62.0%)

PURPOSE

SANITIZER

USES

KILLS 99.99% OF GERMS.

ANTISEPTIC HAND RUB.

WARNINGS

FOR EXTERNAL USE ONLY.

* DO NOT GET INTO EYES.

* FLAMMABLE - Do not use near heat, fire, flame or while smoking. In case of eye contact, flush immediately and thoroughly with water.

SPL UNCLASSIFIED SECTION

* KEEP OUT OF REACH OF CHILDREN. * Do not ingest. If swallowed, seek medical help or call poison control immediately.

* Stop use and ask a doctor if redness and/or irritation occurs and stays longer than 7 days.

DIRECTIONS

Put small amount into palm of hand. Rub together until dry.

OTHER INGREDIENTS

Purified Water, Glycerin, Carbomer, Triethanolamine, Aloe Vera Oil, Aloe Vera Gel, Tocopherol Acetate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62172-118
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62172-118-13	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/30/2020

Labeler - DIVERSIFIED MANUFACTURING CORP (185073996)

Revised: 1/2022

Document Id: d60ee0ff-2558-375e-e053-2a95a90aa97a

Set id: a7e86ca4-669c-4cd3-b080-85e610b87cdf

Version: 3

Effective Time: 20220120