FDA.reportPublic FDA data

Care wipes 70 hand wipes

Manufacturer
2XL Corporation
Effective date
2021-06-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:52

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Benzalkonium Chloride 0.12%

Uses

Uses

For handwashing to decrease bacteria on the skin. After changing diapers. After assisting ill persons. Before contact with a person under medical care or treatment. Recommended for repeated use.

Warnings

Warnings

For external use only.

Directions And Dosage

Directions

Wet hands thoroughly with product and allow to dry. Children under six years of age should be supervised when using this product.

Other Label Information

Inactive ingredients

Water, Aloe Barbadensis Leaf Juice, Polysorbate 20, Glycerin, Potassium Sorbate, Fragrance, Citric Acid, Disodium EDTA, Tocopheryl Acetate (Vitamin E).

Package Labeling:

Label Images#

Label2
Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038741benzalkonium Cl 0.12 % Medicated PadPSN1
1038741benzalkonium chloride 1.2 MG/ML Medicated PadSCD1
1038741benzalkonium chloride 0.12 % Medicated WipeSY1
1038741benzalkonium chloride 0.12 % Topical ClothSY1
1038741benzalkonium chloride 0.12 % Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71995-001-002023-01-30C16284748780-1f386c649-edfa-0266-e053-dadaa90a7c1aCare wipes 70 hand wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71995-001-00Care wipes 70 hand wipes70 in 1 CANISTERCLOTH701
71995-001-00Care wipes 70 hand wipes5 mL in 1 PATCHCLOTH51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71995-001CARE WIPES 70 HAND WIPES (BENZALKONIUM CHLORIDE) CLOTH [2XL CORPORATION]1Legacy NDC, 2 package rows20210617_c4e4f59f-a76d-472d-e053-2995a90a6da2.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71995-00171995-001-00

Ingredients#

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYSORBATE 207T1F30V5YHIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.12%

Uses

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin. After changing diapers. After assisting ill persons. Before contact with a person under medical care or treatment. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry. Children under six years of age should be supervised when using this product.

Other information

SPL UNCLASSIFIED SECTION

Store in a cool, dry place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Leaf Juice, Polysorbate 20, Glycerin, Potassium Sorbate, Fragrance, Citric Acid, Disodium EDTA, Tocopheryl Acetate (Vitamin E).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML