FDA.reportPublic FDA data

Antimicrobial

Manufacturer
McKesson | Central Solutions
Effective date
2024-06-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:13:49

Label at a glance#

ProductAntimicrobial
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Purpose
Antiseptic

INDICATIONS & USAGE SECTION

Uses
a no-rinse topical antiseptic for reducing and inhibiting bacterial growth.

WARNINGS SECTION

Warnings
For external use only.
When using this product

  • do not get into eyes

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Spray soiled and/or odorous (body and/or perineal) areas
  • Gently wipe clean
  • Repeat as necessary until all soils are removed and skin is clean
  • Pat dry
  • No rinsing necessary
  • Apply a protectant cream or paste as necessary

OTHER SAFETY INFORMATION

Store at 40-95ºF (4-35ºC)

INACTIVE INGREDIENT SECTION

Inactive ingredients
Alanine, Aloe Barbadensis Leaf Juice,
Arginine, Aspartic Acid, Butylene Glycol,
Calcium Pantothenate (Vitamin B5),
Caprylyl Glycol, Carthamus Tinctorius
(Safflower) Oleosomes, Chlorphenesin,
Fragrance, Glutamic Acid, Glycerin,
Glycine, Histidine, Isoleucine, Leucine,
Lysine, Maltodextrin, Niacinamide
(Vitamin B3), Phenoxyethanol,
Phenylalanine, Polysorbate 20, Proline,
Pyridoxine HCL (Vitamin B6), Serine,
Silica, Sodium Ascorbyl Phosphate
(Vitamin C), Sodium Hyaluronate,
Sodium Starch Octenylsuccinate,
Tetrasodium EDTA, Threonine,
Tocopheryl Acetate (Vitamin E), Tyrosine,
Valine, Water (may contain Citric Acid,
Sodium Hydroxide)

OTC - QUESTIONS SECTION

Questions?
Call 1-800-777-4908

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-0214-4

McKesson

Thera

ANTIMICROBIAL BODY CLEANSER

A no-rinse topical cleanser for reducing and inhibiting bacterial growth.

Single Patient Use

NET CONTENTS 4 fl. oz (118 mL)

MFR # 53-AC4

eacheach

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL



NDC 68599-0214-8

McKesson

Thera

ANTIMICROBIAL BODY CLEANSER

A no-rinse topical cleanser for reducing and inhibiting bacterial growth.

Single Patient Use

NET CONTENTS 8 fl. oz (237 mL)

MFR # 53-AC8

eacheach

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN6
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD6
1049254benzalkonium chloride 0.13 % Topical SolutionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-0214-4Antimicrobial118 mg in 1 BOTTLELIQUID1186
68599-0214-8Antimicrobial237 mg in 1 BOTTLELIQUID2376

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-0214ANTIMICROBIAL (BODY CLEANSER) LIQUID [MCKESSON]6Current NDC, Legacy NDC, 2 package rows20240619_8ff06cea-3427-5b40-e053-2995a90a0634.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68599-021468599-0214-4, 68599-0214-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROLINE9DLQ4CIU6VIACT
VALINEHG18B9YRS7IACT
LEUCINEGMW67QNF9CIACT
NIACINAMIDE25X51I8RD4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LYSINEK3Z4F929H6IACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
PHENYLALANINE47E5O17Y3RIACT
ARGININE94ZLA3W45FIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
OCTENYLSUCCINIC ACID12UZE4X73LIACT
THREONINE2ZD004190SIACT
GLYCINETE7660XO1CIACT
EDETATE SODIUMMP1J8420LUIACT
HISTIDINE4QD397987EIACT
ISOLEUCINE04Y7590D77IACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
CALCIUM PANTOTHENATE568ET80C3DIACT
MALTODEXTRIN7CVR7L4A2DIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
ASPARTIC ACID30KYC7MIAIIACT
GLUTAMIC ACID3KX376GY7LIACT
ALANINEOF5P57N2ZXIACT
TYROSINE42HK56048UIACT
SERINE452VLY9402IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALOE VERA LEAFZY81Z83H0XIACT
HYALURONATE SODIUMYSE9PPT4THIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
AntimicrobialBODY CLEANSERMcKesson8ff06cea-3427-5b40-e053-2995a90a06342024-06-17WarningsExact identifier
ndc (package): 68599-0214-4
ndc (package): 68599-0214-8
ndc (product): 68599-0214
ndc11 (package): 68599021408
ndc11 (package): 68599021404
spl id: 1b1bc756-8138-771c-e063-6394a90afaa9
spl set id: 8ff06cea-3427-5b40-e053-2995a90a0634

Reported adverse events (FAERS/openFDA)#

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