FDA.reportPublic FDA data

Zep Acclaim AB

Manufacturer
Zep Inc.
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:28:46

Label at a glance#

ProductZep Acclaim AB
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Indications and uses

Hand washing to decrease bacteria on skin.

Dosage and administration

Wet hands with water. Place hands under dispenser and apply liquid soap. Massage soap into hands and wrists, emphasizing back of hands, knuckles, and cuticles.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic Hand Wash

Uses

INDICATIONS & USAGE SECTION

Hand washing to decrease bacteria on skin.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use in the eyes; if in eyes, rinse promptly and thoroughly with water.

When using this product

OTC - WHEN USING SECTION

  • Do not swallow.
  • If swallowed, do not induce vomiting and if individual is conscious, give large quantities of water to drink and consult a physician immediately.

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation or redness persists for more than 72 hours.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children except under adult supervision.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands with water.
  • Place hands under dispenser and apply liquid soap.
  • Massage soap into hands and wrists, emphasizing back of hands, knuckles, and cuticles.

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature.
  • Do not freeze.
  • Dispose in accordance with all applicable federal, state, and local regulations.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cetrimonium Chloride, Lauryl/Myristyl Amidopropyl Amine Oxide, Glycerin, Cocamide DIPA, PEG-120 Methyl Glucose Dioleate, Sodium Chloride, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Fragrance, Yellow 5, Red 4

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-BUY-ZEP (1-877-428-9937)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

131_3149131_3149

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN7
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD7
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY7
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66949-131-01Zep Acclaim AB11400 mL in 1 CASELIQUID114007
66949-131-04Zep Acclaim AB3785 mL in 1 CASELIQUID37857
66949-131-11Zep Acclaim AB6000 mL in 1 CASELIQUID60007
66949-131-16Zep Acclaim AB6000 mL in 1 CASELIQUID60007

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
66949-13166949-131-01, 66949-131-16, 66949-131-11, 66949-131-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SODIUM CHLORIDE451W47IQ8XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
LAUROYL/MYRISTOYL AMIDOPROPYL AMINE OXIDEHY9O6ZW9CYIACT
COCO DIISOPROPANOLAMIDES485AM948QIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
EDETATE SODIUMMP1J8420LUIACT
FD&C RED NO. 4X3W0AM1JLXIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT

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
Zep Acclaim ABBENZALKONIUM CHLORIDEZep Inc.b43bc291-bf12-fea6-e053-2a95a90aa74a2025-12-26WarningsExact identifier
ndc (package): 66949-131-16
ndc (package): 66949-131-04
ndc (package): 66949-131-01
ndc (package): 66949-131-11
ndc (product): 66949-131
ndc11 (package): 66949013104
ndc11 (package): 66949013116
ndc11 (package): 66949013111
ndc11 (package): 66949013101
spl id: 46de7c28-6d26-ead5-e063-6394a90ae31e
spl set id: b43bc291-bf12-fea6-e053-2a95a90aa74a

Reported adverse events (FAERS/openFDA)#

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