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Dictum Surface Disinfectant

Medically reviewed by Drugs.com. Last updated on Aug 21, 2020.

Dosage form: liquid
Ingredients: BENZALKONIUM CHLORIDE 20mg in 1000mg, ALCOHOL 300mg in 1000mg
Labeler: BEB Kozmetik Urunleri Imalat Sanayi Ticaret AS
NDC Code: 79780-103

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)

Alcohol 30% v/v. Purpose: Antiseptic Surface Disinfectant

Purpose

Antiseptic, Surface Disinfectant

Use

Surface Disinfectant to help reduce bacteria that potentially can cause disease. For use surface disinfection.

Warnings

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

Do not use
  • in children less than 2 months of age
  • on open skin wounds

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.

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.

Directions
  • Place enough product on surface to cover all surfaces.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

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

Inactive ingredients

purified water USP

Package Label - Principal Display Panel

DICTUM SURFACE DISINFECTANT 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79780-103
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE20 mg  in 1000 mg
ALCOHOL (ALCOHOL) ALCOHOL300 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:79780-103-01500 mg in 1 BOTTLE, PLASTIC
2NDC:79780-103-021000 mg in 1 BOTTLE, PLASTIC
3NDC:79780-103-034800 mg in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/20/2020
Labeler - BEB Kozmetik Urunleri Imalat Sanayi Ticaret AS (502991071)
Establishment
NameAddressID/FEIOperations
BEB Kozmetik Urunleri Imalat Sanayi Ticaret AS502991071manufacture(79780-103)

 
BEB Kozmetik Urunleri Imalat Sanayi Ticaret AS

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.