FDA.reportPublic FDA data

Ultima DET Antiseptic

Manufacturer
ATLANTIC CARE CHEMICALS PRIVATE LIMITED
Effective date
2020-05-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:04

Label at a glance#

ProductUltima DET Antiseptic
Active ingredientCHLOROXYLENOL
Label structure9 sections

Storage and handling

• Store between 15-30°C (59-86F) • Avoid freezing and excessive heat above 50°C (104F)

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Purpose: Antiseptic

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Component

Chloroxylenol - 5 %

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Isopropyl alcohol, Castor oil, Pine oil, Lauryl alcohol ethoxylate, Methyl ester sulfonate, Water, Caramel colour E150d

INDICATIONS & USAGE SECTION

Use: This product is a specially formulated hand wash soap for hygiene hand washing to decrease microbes on the skin. This concentrated antiseptic hand wash liquid should be diluted with water (1:5 ml) before use.

DOSAGE & ADMINISTRATION SECTION

Directions: Wet hand with fresh water and apply soap. Rub hand together for 20 sec. Rinse hands thoroughly with fresh water.

WARNINGS SECTION

When using this product: keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor: if irritation occurs, please consult a doctor.

Do not use

• In children less than 2 months of age.

• On open skin wounds.

Warning

• For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of Reach of Children

Other information

STORAGE AND HANDLING SECTION

• Store between 15-30°C (59-86F)

• Avoid freezing and excessive heat above 50°C (104F)

SPL UNCLASSIFIED SECTION

Manufactured by:
Atlantic Care Chemicals. Pvt. Ltd
Industrial Development Plot,
Alappuzha, Kerala, India.

9001:2015

ISO CERTIFIED COMPANY

PASSION FOR INNOVATION

care@atlanticchemicals.com
www.atlanticchemicals.com

MADE IN INDIA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultma1Ultma1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
436367chloroxylenol 0.5 % Medicated Liquid SoapPSN1
436367chloroxylenol 5 MG/ML Medicated Liquid SoapSCD1
436367chloroxylenol 0.5 % Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77249-107-012022-01-28C16284748780-1d6a99b39-f395-a426-e053-dadaa90af4c2ultima DET Concentrated Antiseptic Hand wash
77249-107-022022-01-28C16284748780-1d6a99b39-f395-a426-e053-dadaa90af4c2ultima DET Concentrated Antiseptic Hand wash
77249-107-052022-01-28C16284748780-1d6a99b39-f395-a426-e053-dadaa90af4c2ultima DET Concentrated Antiseptic Hand wash
77249-107-452022-01-28C16284748780-1d6a99b39-f395-a426-e053-dadaa90af4c2ultima DET Concentrated Antiseptic Hand wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77249-107-01Ultima DET Antiseptic0.1 L in 1 BOTTLELIQUID0.11
77249-107-02Ultima DET Antiseptic0.2 L in 1 BOTTLELIQUID0.21
77249-107-05Ultima DET Antiseptic0.5 L in 1 BOTTLELIQUID0.51
77249-107-45Ultima DET Antiseptic5 L in 1 CANLIQUID51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77249-107ULTIMA DET ANTISEPTIC (CHLOROXYLENOL) LIQUID [ATLANTIC CARE CHEMICALS PRIVATE LIMITED]1Legacy NDC, 4 package rows20200529_43cef93f-6f21-4c1c-8ad8-e2500f74e9c2.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77249-10777249-107-45, 77249-107-01, 77249-107-02, 77249-107-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLOROXYLENOL0F32U78V2QACTIB
ISOPROPYL ALCOHOLND2M416302IACT
CASTOR OILD5340Y2I9GIACT
WHITE PINE OILHA5CX6676UIACT
LAURYL ALCOHOL178A96NLP2IACT
S-METHYL METHANETHIOSULFONATE0906Z2356UIACT
WATER059QF0KO0RIACT
CARAMELT9D99G2B1RIACT

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
f29fc7f3-7016-455d-884d-30f37976a23f43cef93f-6f21-4c1c-8ad8-e2500f74e9c22020-05-21WarningsExact identifier
spl id: f29fc7f3-7016-455d-884d-30f37976a23f
spl set id: 43cef93f-6f21-4c1c-8ad8-e2500f74e9c2

Reported adverse events (FAERS/openFDA)#

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