FDA.reportPublic FDA data

Fresh Water

Manufacturer
Spa Dent Inc | Apollo Health and Beauty Care
Effective date
2021-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:38

Label at a glance#

ProductFresh Water
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

Helps eliminate bacteria on hands

Dosage and administration

use to refill a hand soap pump bottle. From pump bottle, apply onto wet hands. Lather and rinse thoroughly.

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active Ingredient.

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride (0.13%)

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

Helps eliminate bacteria on hands

Warnings

WARNINGS SECTION

For external use only 

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes. In case of contact, rinse thoroughly with water. 

Stop use and ask a doctor.

OTC - STOP USE SECTION

If irritation or redness develops and lasts

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use to refill a hand soap pump bottle.
  • From pump bottle, apply onto wet hands.
  • Lather and rinse thoroughly.

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (Cl 16035), Yellow 5 (Cl 19140), Red 33 (Cl 17200).

Questions or comments ?

OTC - QUESTIONS SECTION

1-800-925-4733

PDP04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP04PDP04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79147-022-042023-01-30C16284748780-1f386c64a-1b27-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79147-022-04Fresh Water1660 mL in 1 BOTTLE, PLASTICSOAP16601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79147-022FRESH WATER (BENZALKONIUM CHLORIDE) SOAP [SPA DENT INC]1Legacy NDC, 1 package rows20210724_86dfc5b3-768a-4d7b-9911-6a3f0cb00413.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79147-02279147-022-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
GLYCERINPDC6A3C0OXIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
SODIUM CHLORIDE451W47IQ8XIACT
COCO MONOETHANOLAMIDEC80684146DIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM SULFATE0YPR65R21JIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 339DBA0SBB0LIACT

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
3c220fac-7017-404b-82df-eecfb09cceea86dfc5b3-768a-4d7b-9911-6a3f0cb004132021-07-23WarningsExact identifier
spl id: 3c220fac-7017-404b-82df-eecfb09cceea
spl set id: 86dfc5b3-768a-4d7b-9911-6a3f0cb00413

Reported adverse events (FAERS/openFDA)#

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