FDA.reportPublic FDA data

Hand Sanitizer Wipes

Manufacturer
PDD Design LLC
Effective date
2020-12-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:34:46

Label at a glance#

ProductHand Sanitizer Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure16 sections

Dosage and administration

Adults and children 3 years and over Children under 3 years ask a doctor before use Wipe with wipes and let dry

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1% v/v. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Kill germs and remove dirt

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

if you are allergic to any of ingredients

OTC - WHEN USING SECTION

When using this product do not get into eyes. If contact occurs, wash thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash develops and continuous for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 3 years and over

Children under 3 years ask a doctor before use

Wipe with wipes and let dry

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Cool Wipes Baby with Plantain Extract - Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene glycol, Plantago Major Leaf, Peg-40 Hydrogenated Castor Oil, Cocamidopropyl Betaine, PPG-2 Methyl Ether, Ethylparaben, 2-Bromo-2-Nitropropane- 1,3-Diol, Ethylparaben, Cetrimonium Bromide, Citric Acid, Parfum

Cool Wipes Safe Clean enriched with vitamins - Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene glycol, Tocopheryl acetate, Sodium Ascorbyl Phosphate, Retinyl Palmitate, Panthenol, Peg-40 Hydrogenated Castor Oil, Cocamidopropyl Betaine, PPG-2 Methyl Ether, Ethylparaben, 2-Bromo-2-Nitropropane- 1,3-Diol, Citric Acid, Parfum, Limonene, Citral

Cool Wipes Safe Clean enriched with plantain extract

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene glycol, Plantago Major Leaf, Peg-40 Hydrogenated Castor Oil, Cocamidopropyl Betaine, PPG-2 Methyl Ether, Ethylparaben, 2-Bromo-2-Nitropropane- 1,3-Diol, Ethylparaben, Cetrimonium Bromide, Citric Acid, Parfum

Cool Wipes Safe Clean enriched with plantain extract - Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15 Wipes NDC:77848-001-15

15 wipes15 wipes

Cool Wipes Safe Clean enriched with vitamins - Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15 Wipes NDC: 77848-002-15

15 wipes15 wipes

Cool Wipes Baby with Plantain Extract - Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15 wipes NDC: 77848-003-15

15 wipes15 wipes

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77848-001-152022-01-28C16284748780-1d6a99b39-6644-a426-e053-dadaa90af4c2a6dea22c-12dd-0723-e053-2995a90aa1af
77848-002-152022-01-28C16284748780-1d6a99b39-6644-a426-e053-dadaa90af4c2a6dea22c-12dd-0723-e053-2995a90aa1af
77848-003-152022-01-28C16284748780-1d6a99b39-6644-a426-e053-dadaa90af4c2a6dea22c-12dd-0723-e053-2995a90aa1af

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77848-001-15Hand Sanitizer Wipes15 mL in 1 PACKETSOLUTION152
77848-002-15Hand Sanitizer Wipes15 mL in 1 PACKETSOLUTION152
77848-003-15Hand Sanitizer Wipes15 mL in 1 CARTONSOLUTION152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77848-001HAND SANITIZER WIPES (ALCOHOL) SOLUTION [PDD DESIGN LLC]2Legacy NDC, 1 package rows20201209_a6dea22c-12dd-0723-e053-2995a90aa1af.zip
77848-002HAND SANITIZER WIPES (ALCOHOL) SOLUTION [PDD DESIGN LLC]2Legacy NDC, 1 package rows20201209_a6dea22c-12dd-0723-e053-2995a90aa1af.zip
77848-003HAND SANITIZER WIPES (ALCOHOL) SOLUTION [PDD DESIGN LLC]2Legacy NDC, 1 package rows20201209_a6dea22c-12dd-0723-e053-2995a90aa1af.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77848-00377848-003-15
77848-00177848-001-15
77848-00277848-002-15

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PPG-2 METHYL ETHERRQ1X8FMQ9NIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
PLANTAGO MAJOR LEAF7DC28K241XIACT
ETHYLPARABEN14255EXE39IACT
CETRIMONIUM BROMIDEL64N7M9BWRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
2-NITROPROPANEGKV234L2QHIACT
PLANTAGO MAJOR LEAF7DC28K241XIACT
ETHYLPARABEN14255EXE39IACT
CETRIMONIUM BROMIDEL64N7M9BWRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PPG-2 METHYL ETHERRQ1X8FMQ9NIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PPG-2 METHYL ETHERRQ1X8FMQ9NIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ETHYLPARABEN14255EXE39IACT
CETRIMONIUM BROMIDEL64N7M9BWRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
2-NITROPROPANEGKV234L2QHIACT
LIMONENE, (+)-GFD7C86Q1WIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
PANTHENOLWV9CM0O67ZIACT

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
b5b8b9f1-d9eb-aa3e-e053-2a95a90a551ea6dea22c-12dd-0723-e053-2995a90aa1af2020-12-05WarningsExact identifier
spl id: b5b8b9f1-d9eb-aa3e-e053-2a95a90a551e
spl set id: a6dea22c-12dd-0723-e053-2995a90aa1af

Reported adverse events (FAERS/openFDA)#

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