FDA.reportPublic FDA data

Benzalkonium Chloride

Manufacturer
McKesson
Effective date
2019-08-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:15:49

Label at a glance#

ProductBenzalkonium Chloride
Active ingredientBENZALKONIUM CHLORIDE
Label structure14 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Dimethicone 5%

OTC - PURPOSE SECTION

Purpose
Skin Protectant

INDICATIONS & USAGE SECTION

Uses

  • temporarily protects and helps relieve chapped or cracked skin
  • beneficial for face, hands, body and legs

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

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

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
Apply cream liberally as needed

OTHER SAFETY INFORMATION

Store at 40-95ºF (4-35ºC).

INACTIVE INGREDIENT SECTION

Purified Water, Aleurites Moluccana Seed Oil, Stearic Acid, Cetyl Alcohol, Glycerin, Glyceryl Stearate,
PEG 100 Stearate, Carthamus Tinctorius (Safflower) Seed Oil, Dimethicone Crosspolymer, Butylene Glycol,
Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract,
Carthamus Tinctorius (Safflower) Oleosomes, Calcium Pantothenate (Vitamin B5), Maltodextrin,
Niacinamide (Vitamin B3), Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C),
Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E), Bisabolol, Lysine, Histidine,
Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine,
Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine, Fragrance, Phenoxyethanol,
Caprylyl Glycol, Chlorphenesin, Disodium EDTA, Triethanolamine

OTC - QUESTIONS SECTION

Questions?
Call 1-800-777-4908

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 68599-0218-4
McKesson
Thera
MOISTURIZING BODY CREAM
Everyday moisturizer and skin conditioner.
Single Patient Use
NET CONTENTS 4 fl oz (118 mL)
MFR # 53-CRM4

53-CRM453-CRM4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 68599-0218-1
McKesson
Thera
MOISTURIZING BODY CREAM
Refill for McKesson Pump Dispenser MFR # 53-1000.
NET CONTENTS 1000 mL (34 fl. oz.)
MFR # 53-CRM1000

53-CRM100053-CRM1000

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-0218-8
McKesson
Thera
MOISTURIZING BODY CREAM
Everyday moisturizer and skin conditioner.
Single Patient Use
NET CONTENTS 32 fl oz (946 mL)
MFR # 53-CRM32

53-CRM3253-CRM32

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68599-021168599-0211-4, 68599-0211-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HISTIDINE4QD397987EIACT
SERINE452VLY9402IACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
NIACINAMIDE25X51I8RD4IACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
OCTENYLSUCCINIC ACID12UZE4X73LIACT
ARGININE94ZLA3W45FIACT
HYALURONATE SODIUMYSE9PPT4THIACT
CHLORPHENESINI670DAL4SZIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
LEUCINEGMW67QNF9CIACT
ALANINEOF5P57N2ZXIACT
METHIONINEAE28F7PNPLIACT
PHENYLALANINE47E5O17Y3RIACT
TYROSINE42HK56048UIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
POLYSORBATE 207T1F30V5YHIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ASPARTIC ACID30KYC7MIAIIACT
PROLINE9DLQ4CIU6VIACT
ISOLEUCINE04Y7590D77IACT
EDETATE SODIUMMP1J8420LUIACT
LYSINEK3Z4F929H6IACT
THREONINE2ZD004190SIACT
GLUTAMIC ACID3KX376GY7LIACT
GLYCINETE7660XO1CIACT
VALINEHG18B9YRS7IACT
CYSTEINEK848JZ4886IACT

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
b5df9e78-70ae-85a6-e053-2995a90a1e1c8faebb5c-e484-b3dc-e053-2a95a90a44912020-12-07WarningsExact identifier
spl set id: 8faebb5c-e484-b3dc-e053-2a95a90a4491

Reported adverse events (FAERS/openFDA)#

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