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NDC 64596-0222-99 Instant Hand Sanitizer 0.13 g/100mL Details

Instant Hand Sanitizer 0.13 g/100mL

Instant Hand Sanitizer is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Gilchrist & Soames. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	64596-0222
Product ID	64596-222_a693d3d0-47a5-6ff9-e053-2a95a90a6c4c
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	Instant Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hand sanitizer
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	0.13
Active Ingredient Units	g/100mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Gilchrist & Soames
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 64596-0222-99 (64596022299)

Pricing Information	N/A
NDC Package Code	64596-222-99
Billing NDC	64596022299
Package	3785 mL in 1 BOTTLE, PLASTIC (64596-222-99)
Marketing Start Date	2020-04-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a6938c40-b41f-e67b-e053-2995a90ad0d5 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

37 mL NDC: 64596-222-37

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER

hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64596-222
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
HEXYLENE GLYCOL (UNII: KEH0A3F75J)	0.02 g in 100 mL
WATER (UNII: 059QF0KO0R)	93.33 mL in 100 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	0.23 g in 100 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.08 g in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.26 g in 100 mL
POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)	0.8 g in 100 mL
ALCOHOL (UNII: 3K9958V90M)	5 g in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64596-222-37	37 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/30/2020

Labeler - Gilchrist & Soames (052683856)

Registrant - Gilchrist & Soames (052683856)

Name	Address	ID/FEI	Business Operations
Establishment
Gilchrist & Soames		052683856	manufacture(64596-222)

Revised: 5/2020

Document Id: a693d3d0-47a5-6ff9-e053-2a95a90a6c4c

Set id: a6938c40-b41f-e67b-e053-2995a90ad0d5

Version: 1

Effective Time: 20200526

Search by Drug Name or NDC

NDC 64596-0222-99 Instant Hand Sanitizer 0.13 g/100mL Details

Instant Hand Sanitizer 0.13 g/100mL

Product Information

Package

Package Images

NDC 64596-0222-99 (64596022299)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a6938c40-b41f-e67b-e053-2995a90ad0d5 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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