FDA.reportPublic FDA data

New Life Antibacterial HandSoap

Manufacturer
New Life Products, Inc.
Effective date
2023-02-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:53:41

Label at a glance#

ProductNew Life Antibacterial HandSoap
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

• Hand soap to decrease bacteria on skin. • Recommended for repeated use.

Dosage and administration

• Apply to hands and wet as needed. Lather vigorously for at least 15 second. Wash skin, rinse thoroughly and dry • Children under 6 years of age should be supervised by an adult when using this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

• Hand soap to decrease bacteria on skin. • Recommended for repeated use.

Warnings:

WARNINGS SECTION

For external use only.

Flammable. Keep away from fire or flame.

When using this product avoid contact with face, eyes, and broken skin. If eye contact occurs, flush thoroughly with water and seek medical advice.

Stop use and ask doctor if irritation and redness develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply to hands and wet as needed. Lather vigorously for at least 15 second. Wash skin, rinse thoroughly and dry

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water (Aqua), Lauramidopropylamine Oxide, Lauramine Oxide, Cocamidopropyl Betaine, Glycerin, Cetrimonium Chloride, Citric Acid, Tetrasodium EDTA, PEG-150 Distearate, Sodium Chloride, Sodium Benzoate, Phenoxyethanol, Fragrance (Parfum), Orange 4 (CI 15510), Yellow 6 (CI 15985).

SPL UNCLASSIFIED SECTION

Kills Germs +

Gently Cleanses & Moisturizes

ORIGINAL

AFAM CONCEPT, Inc. • Chicago, IL 60629

Watford WD24 7GN, UK • 800-262-2326

www.newlifesanitizer.com

cruelty free

MADE IN USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackagingPackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN4
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD4
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY4
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49681-015-102024-07-30C16284748780-1f386c64a-1f83-0266-e053-dadaa90a7c1anew life TM Antibacterial Hand Soap
49681-015-182024-07-30C16284748780-1f386c64a-1f83-0266-e053-dadaa90a7c1anew life TM Antibacterial Hand Soap
49681-015-102024-01-30C16284748780-1f386c64a-1f83-0266-e053-dadaa90a7c1anew life TM Antibacterial Hand Soap
49681-015-182024-01-30C16284748780-1f386c64a-1f83-0266-e053-dadaa90a7c1anew life TM Antibacterial Hand Soap
49681-015-102023-02-02C16284748780-1f386c64a-1f83-0266-e053-dadaa90a7c1anew life TM Antibacterial Hand Soap
49681-015-182023-02-02C16284748780-1f386c64a-1f83-0266-e053-dadaa90a7c1anew life TM Antibacterial Hand Soap
49681-015-102023-01-30C16284748780-1f386c64a-1f83-0266-e053-dadaa90a7c1anew life TM Antibacterial Hand Soap
49681-015-182023-01-30C16284748780-1f386c64a-1f83-0266-e053-dadaa90a7c1anew life TM Antibacterial Hand Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49681-015-10New Life Antibacterial HandSoap295 mL in 1 BOTTLELIQUID2954
49681-015-18New Life Antibacterial HandSoap532 mL in 1 BOTTLELIQUID5324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49681-015NEW LIFE ANTIBACTERIAL HANDSOAP (BENZALKONIUM CHLORIDE) LIQUID [NEW LIFE PRODUCTS, INC.]4Legacy NDC, 2 package rows20230203_8b44f267-e871-427d-ab02-a79d6783035c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49681-01549681-015-10, 49681-015-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
D&C ORANGE NO. 4Q1LIY3BO0UIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
851f6403-2e5b-401e-bbfc-dee03fa1a8028b44f267-e871-427d-ab02-a79d6783035c2023-02-02WarningsExact identifier
spl id: 851f6403-2e5b-401e-bbfc-dee03fa1a802
spl set id: 8b44f267-e871-427d-ab02-a79d6783035c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.