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NDC 59883-0301-06 Hand Sanitizer 80 mL/100mL Details

Hand Sanitizer 80 mL/100mL

Hand Sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Den-Mat Holdings, LLC. The primary component is ALCOHOL.

Product Information

NDC	59883-0301
Product ID	59883-301_d803b9bb-6801-6639-e053-2a95a90a3f9f
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	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	80
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Den-Mat Holdings, LLC
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 59883-0301-06 (59883030106)

Pricing Information	N/A
NDC Package Code	59883-301-06
Billing NDC	59883030106
Package	147 mL in 1 BOTTLE, DISPENSING (59883-301-06)
Marketing Start Date	2020-07-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ab34244e-7b53-db0d-e053-2995a90a6bd4 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient(s)

Alcohol 80% v/v.

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

in children less than 2 months of age
on open skin wounds

SPL UNCLASSIFIED SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

147 mL NDC: 59883-301-06

473mL

INGREDIENTS AND APPEARANCE

HAND SANITIZER

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59883-301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59883-301-06	147 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/21/2020
2	NDC:59883-301-17	473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/21/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/21/2020

Labeler - Den-Mat Holdings, LLC (809857704)

Name	Address	ID/FEI	Business Operations
Establishment
Den-Mat Holdings, LLC		809857704	manufacture(59883-301) , pack(59883-301) , label(59883-301)

Revised: 2/2022

Document Id: d803b9bb-6801-6639-e053-2a95a90a3f9f

Set id: ab34244e-7b53-db0d-e053-2995a90a6bd4

Version: 2

Effective Time: 20220214

Search by Drug Name or NDC

NDC 59883-0301-06 Hand Sanitizer 80 mL/100mL Details

Hand Sanitizer 80 mL/100mL

Product Information

Package

Package Images

NDC 59883-0301-06 (59883030106)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ab34244e-7b53-db0d-e053-2995a90a6bd4 Details

SPL UNCLASSIFIED SECTION

Active Ingredient(s)

Purpose

Use

Warnings

Do not use

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

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