FDA.reportPublic FDA data

Dictum Surface Disinfectant

Manufacturer
BEB Kozmetik Urunleri Imalat Sanayi Ticaret AS
Effective date
2020-11-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:34:01

Label at a glance#

ProductDictum Hand and Skin Disinfectant
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (0.3% v/v).
  3. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING 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 or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label SmallLabel Small

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN4
582753ethanol 0.7 ML/ML Topical SolutionSCD4
582753ethanol 70 % Topical SolutionSY4
582753ethyl alcohol 70 % Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79780-101-012022-01-28C16284748780-1d6a99b39-650b-a426-e053-dadaa90af4c2a96a8d6b-7324-7205-e053-2995a90a6b89
79780-101-022022-01-28C16284748780-1d6a99b39-650b-a426-e053-dadaa90af4c2a96a8d6b-7324-7205-e053-2995a90a6b89
79780-101-032022-01-28C16284748780-1d6a99b39-650b-a426-e053-dadaa90af4c2a96a8d6b-7324-7205-e053-2995a90a6b89
79780-101-042022-01-28C16284748780-1d6a99b39-650b-a426-e053-dadaa90af4c2a96a8d6b-7324-7205-e053-2995a90a6b89
79780-101-052022-01-28C16284748780-1d6a99b39-650b-a426-e053-dadaa90af4c2a96a8d6b-7324-7205-e053-2995a90a6b89
79780-101-062022-01-28C16284748780-1d6a99b39-650b-a426-e053-dadaa90af4c2a96a8d6b-7324-7205-e053-2995a90a6b89
79780-101-072022-01-28C16284748780-1d6a99b39-650b-a426-e053-dadaa90af4c2a96a8d6b-7324-7205-e053-2995a90a6b89
79780-101-082022-01-28C16284748780-1d6a99b39-650b-a426-e053-dadaa90af4c2a96a8d6b-7324-7205-e053-2995a90a6b89

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79780-101-01Dictum Hand and Skin Disinfectant50 mL in 1 BOTTLE, PLASTICLIQUID504
79780-101-02Dictum Hand and Skin Disinfectant100 mL in 1 BOTTLE, PLASTICLIQUID1004
79780-101-03Dictum Hand and Skin Disinfectant250 mL in 1 BOTTLE, PLASTICLIQUID2504
79780-101-04Dictum Hand and Skin Disinfectant500 mL in 1 BOTTLE, PLASTICLIQUID5004
79780-101-05Dictum Hand and Skin Disinfectant1000 mL in 1 BOTTLE, PLASTICLIQUID10004
79780-101-06Dictum Hand and Skin Disinfectant5000 mL in 1 DRUMLIQUID50004
79780-101-07Dictum Hand and Skin Disinfectant10000 mL in 1 DRUMLIQUID100004
79780-101-08Dictum Hand and Skin Disinfectant20000 mL in 1 DRUMLIQUID200004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79780-101DICTUM HAND AND SKIN DISINFECTANT (ALCOHOL) LIQUID [BEB KOZMETIK URUNLERI IMALAT SANAYI TICARET AS]4Legacy NDC, 8 package rows20201121_a96a8d6b-7324-7205-e053-2995a90a6b89.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79780-10179780-101-01, 79780-101-02, 79780-101-03, 79780-101-04, 79780-101-05, 79780-101-06, 79780-101-07, 79780-101-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
b487fcbb-301c-83b0-e053-2a95a90a4351a96a8d6b-7324-7205-e053-2995a90a6b892020-11-20WarningsExact identifier
spl id: b487fcbb-301c-83b0-e053-2a95a90a4351
spl set id: a96a8d6b-7324-7205-e053-2995a90a6b89

Reported adverse events (FAERS/openFDA)#

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