FDA.reportPublic FDA data

Dans Anti-bacterial Bar

Manufacturer
HADA International S.A | HADA International S.A.
Effective date
2020-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:34:50

Label at a glance#

ProductDans Anti-bacterial Bar Oat / Avena
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium Chloride 0.1%

OTC - PURPOSE SECTION

Purpose

Antibacterial

INDICATIONS & USAGE SECTION

Use for washing to decrease bacteria on the skin

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes, in case of eye contact, flush with water

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develop

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

  • Wet bar with water
  • Lather vigorously and wash skin
  • Rinse and dry thoroughly

INACTIVE INGREDIENT SECTION

Inactive ingredients Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Sodium Chloride, Avena Sativa (Oat) Bran, Fragrance, Etidronic Acid, Titanium Dioxide, Tetrasodium EDTA, Hydrolyzed Collagen, Coumarin, Geraniol, Linalool, Yellow #10 (CI 47005), Red No. 4 (CI 14700).

SPL UNCLASSIFIED SECTION

Manufactured by:

HADA INTERNATIONAL, S.A.

Zona Franca La Cayena Km 8 LT7MZ8

Barranquilla, Columbia

Made in Columbia

Calls USA: +1 (787)7856822

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hada Dans®
ANTIBACTERIAL BAR SOAP
OAT / AVENA
With Collagen
NET WT 4.4 OZ (125g)

Dans 125g AVENA 2019Dans 125g AVENA 2019

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42377-010-042023-04-28C16284748780-1f386c649-e2fc-0266-e053-dadaa90a7c1aDans Anti-bacterial Bar Soap Oat
42377-010-142023-04-28C16284748780-1f386c649-e2fc-0266-e053-dadaa90a7c1aDans Anti-bacterial Bar Soap Oat
42377-010-042023-01-30C16284748780-1f386c649-e2fc-0266-e053-dadaa90a7c1aDans Anti-bacterial Bar Soap Oat
42377-010-142023-01-30C16284748780-1f386c649-e2fc-0266-e053-dadaa90a7c1aDans Anti-bacterial Bar Soap Oat

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42377-01042377-010-04, 42377-010-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 3500 MW)5WE8P977RQIACT
LINALOOL, (+/-)-D81QY6I88EIACT
FD&C RED NO. 4X3W0AM1JLXIACT
GLYCERINPDC6A3C0OXIACT
OAT BRANKQX236OK4UIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
SODIUM PALMATES0A6004K3ZIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
GERANIOLL837108USYIACT
SODIUM CHLORIDE451W47IQ8XIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
COUMARINA4VZ22K1WTIACT
ETIDRONIC ACIDM2F465ROXUIACT
EDETATE SODIUMMP1J8420LUIACT
D&C YELLOW NO. 1035SW5USQ3GIACT

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
fa69e5cd-b0c8-ae9a-e053-6394a90a855fa036d512-e2cb-bb9f-e053-2995a90a1d282023-04-28WarningsExact identifier
spl set id: a036d512-e2cb-bb9f-e053-2995a90a1d28

Reported adverse events (FAERS/openFDA)#

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