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NDC 52651-0007-04 TN DIckinsons Antiseptic Hand Sanitizer 80 mL/100mL Details

TN DIckinsons Antiseptic Hand Sanitizer 80 mL/100mL

TN DIckinsons Antiseptic Hand Sanitizer is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Dickinson Brands Inc.. The primary component is ALCOHOL.

Product Information

NDC	52651-0007
Product ID	52651-007_3fbfd9cf-bcd3-4745-8f25-71ed0528a112
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	TN DIckinsons Antiseptic Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	80
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Dickinson Brands Inc.
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 52651-0007-04 (52651000704)

Pricing Information	N/A
NDC Package Code	52651-007-04
Billing NDC	52651000704
Package	3785 mL in 1 JUG (52651-007-04)
Marketing Start Date	2020-04-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7c12e2af-1a48-472a-8026-7274d854b63d Details

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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.

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

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

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

No Rinse Skin Cleanser

T.N. Dickinsons Hand Sanitizer

80% Alcohol Antiseptic

Topical Solution

Helps reduce

bacteria that

potentially can

cause disease

Non-Sterile

Solution

8 FL. OZ. (237 mL)

INGREDIENTS AND APPEARANCE

TN DICKINSONS ANTISEPTIC HAND SANITIZER

alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52651-007
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)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)	18.425 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52651-007-05	237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/31/2020
2	NDC:52651-007-04	3785 mL in 1 JUG; Type 0: Not a Combination Product	04/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/31/2020

Labeler - Dickinson Brands Inc. (124620340)

Name	Address	ID/FEI	Business Operations
Establishment
American Distilling Inc.		065524738	manufacture(52651-007)

Revised: 1/2022

Document Id: 3fbfd9cf-bcd3-4745-8f25-71ed0528a112

Set id: 7c12e2af-1a48-472a-8026-7274d854b63d

Version: 3

Effective Time: 20220126

Search by Drug Name or NDC

NDC 52651-0007-04 TN DIckinsons Antiseptic Hand Sanitizer 80 mL/100mL Details

TN DIckinsons Antiseptic Hand Sanitizer 80 mL/100mL

Product Information

Package

Package Images

NDC 52651-0007-04 (52651000704)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7c12e2af-1a48-472a-8026-7274d854b63d 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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