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NDC 69842-0584-01 CVS Foaming Hand Sanitizer 1.3 mg/mL Details

CVS Foaming Hand Sanitizer 1.3 mg/mL

CVS Foaming Hand Sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Health. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	69842-0584
Product ID	69842-584_90febb8c-1c79-4260-bbc7-39e2a4c2e9c3
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	CVS Foaming Hand Sanitizer
Proprietary Name Suffix	Antibacterial
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	CVS Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0584-01 (69842058401)

Pricing Information	N/A
NDC Package Code	69842-584-01
Billing NDC	69842058401
Package	222 mL in 1 BOTTLE, DISPENSING (69842-584-01)
Marketing Start Date	2015-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 90ad0d77-cc40-46f2-99ac-2d358aee6d01 Details

Drug Facts

Active ingredients

Benzalkonium Chloride 0.13

Purpose

Antibacterial

Uses

♦: hand sanitizer to help reduce bacteria on the skin that could cause disease
♦: Recommended for repeated use

Warnings

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.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions

♦: place 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

♦: To prevent discoloration, avoid contact with clothing.

Inactive ingredients

Cetrimonium Chloride, Citric Acid, Cocamidopropylamine Oxide, Cocamidopropyl Betaine, Glycerin, Propylene Glycol, Water.

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 222 mL Bottle Label

♥CVS

Health™

Foaming

Hand

Sanitizer

INSTANT

Antibacterial
Alcohol free

KILLS

99.99%

OF GERMS*

Unscented

7.5 FL OZ (222 mL)

*Effective at eliminating more than 99.99%

or many common harmful germs and

bacteria in as little as 15 seconds.

05-3201

L0015035FB

PRINCIPAL DISPLAY PANEL - 222 mL Bottle Label

INGREDIENTS AND APPEARANCE

CVS FOAMING HAND SANITIZER ANTIBACTERIAL

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-584
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Cetrimonium Chloride (UNII: UC9PE95IBP)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Cocamidopropylamine Oxide (UNII: M4SL82J7HK)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-584-01	222 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part333E	01/01/2015

Labeler - CVS Health (062312574)

Registrant - Garcoa, Inc. (036464697)

Name	Address	ID/FEI	Business Operations
Establishment
Garcoa, Inc.		036464697	MANUFACTURE(69842-584)

Revised: 1/2022

Document Id: 90febb8c-1c79-4260-bbc7-39e2a4c2e9c3

Set id: 90ad0d77-cc40-46f2-99ac-2d358aee6d01

Version: 2

Effective Time: 20220125