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NDC 49922-0976-01 Secure Gel Hand Sanitizer 70 mL/100mL Details

Secure Gel Hand Sanitizer 70 mL/100mL

Secure Gel Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by American Cleaning Solutions. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	49922-0976
Product ID	49922-976_f9fde749-71ec-483f-81bc-ebc4b2422281
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	Secure Gel Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	American Cleaning Solutions
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	n/a

Package

Package Images

NDC 49922-0976-01 (49922097601)

Pricing Information	N/A
NDC Package Code	49922-976-01
Billing NDC	49922097601
Package	3785 mL in 1 BOTTLE (49922-976-01)
Marketing Start Date	2020-07-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 03f94af9-9c90-4f2a-9995-7127d5239320 Details

Drug Facts

Active Ingredient

Isopropyl Alcohol 70% v/v

Purpose

Antiseptic

SPL UNCLASSIFIED SECTION

Uses Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and

water are not available.

WARNING

Flammable. Keep away from fire or flame.

This product is intended for external use only.

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• Apply enough product in your palm to thoroughly cover your hands.

• Rub hands together briskly until dry.

• Children under 6 years of age should be supervised when using this product.

Other Information

• Store Between 15-30°C (59-86°F)

• Avoid freezing and excessive heat above 40°C (104°F)

SPL UNCLASSIFIED SECTION

Inactive Ingredients glycerin, hydrogen peroxide, purified water USP, Hydroxyethyl Cellulose.

SPL UNCLASSIFIED SECTION

Desanizador Viscoso de Manos

Topical Solution

Non-sterile Solution

• Contains 70% Isopropyl Alcohol

• Anti-Bacterial Properties

• Leaves Hands Feeling Clean and Smooth

• Contains Natural Moisturizer

• No Water Necessary

Hand Soaps & Shampoos

This product is a semi-viscous blend of 70% Isopropyl Alcohol, Hydrogen Peroxide and Emollients.

• No Rinsing Required.

• No water or paper towels needed.

• Leaves hands feeling soft & refreshed. No sticky residue.

CONTAINS: 2-propanol (67-63-0), Water (7732-18-5), Glycerol (56-81-5), Hydrogen Peroxide,

aqueous solution (7722-84-1), Hydroxyethyl Cellulose(9032-42-2).

Expiration: 7/2022

AMERICAN Cleaning Solutions

Division of American Wax Company. Inc

39-30 Review Avenue

Long Island City, New York 11101

888 WAX PLUS • (718) 392-8080 • Fax: (718) 482-9366

SDS available at www.cleaning-solutions.com

See FOCUS Green products at www.focus-acs.com

Packaging

INGREDIENTS AND APPEARANCE

SECURE GEL HAND SANITIZER

isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49922-976
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49922-976-21	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2020	12/29/2023
2	NDC:49922-976-41	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2020	12/29/2023
3	NDC:49922-976-81	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2020	12/29/2023
4	NDC:49922-976-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2020	12/29/2023
5	NDC:49922-976-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2020	12/29/2023
6	NDC:49922-976-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2020	12/29/2023
7	NDC:49922-976-05	18925 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/23/2020	12/29/2023
8	NDC:49922-976-30	113550 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/23/2020	12/29/2023
9	NDC:49922-976-55	208150 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/23/2020	12/29/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/23/2020	12/29/2023

Labeler - American Cleaning Solutions (001321017)

Name	Address	ID/FEI	Business Operations
Establishment
American Cleaning Solutions		001321017	manufacture(49922-976)

Revised: 12/2021

Document Id: f9fde749-71ec-483f-81bc-ebc4b2422281

Set id: 03f94af9-9c90-4f2a-9995-7127d5239320

Version: 2

Effective Time: 20211221

Search by Drug Name or NDC

NDC 49922-0976-01 Secure Gel Hand Sanitizer 70 mL/100mL Details

Secure Gel Hand Sanitizer 70 mL/100mL

Product Information

Package

Package Images

NDC 49922-0976-01 (49922097601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 03f94af9-9c90-4f2a-9995-7127d5239320 Details

Drug Facts

Active Ingredient

Purpose

SPL UNCLASSIFIED SECTION

WARNING

DIRECTIONS

Other Information

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Packaging

INGREDIENTS AND APPEARANCE

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