Deep Fresh Antibacterial Hand Gel

Manufacturer
AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
Effective date
2022-01-23
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 22:10:43

Label at a glance#

ProductDeep Fresh Antibacterial Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Take some Antibacterial gel in your hand. Rub your hands, between the fingers, all the inner and outer surfaces, the nails, until they dry. It is used for hand cleaning. Do not rinse after use.

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 (0.5% v/v).
  3. Carbomer (0.35% v/v).
  4. Triethanolamine (0.1% v/v).
  5. 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 70% v/v. Purpose: Antibacterial

Purpose

OTC - PURPOSE SECTION

Antibacterial Hand Gel

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 fire,flame,sparks and heat. Keep away from children, food and animal feeds.

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

Do not inhale the vapour or grains of the product if occurs. In case of inhaling: If you feel uncomfortable get some fresh air.In case of contact with eyes:If you are wearing contact lenses, remove them immediately.Rinse your eyes with plenty of clean water. Seek for medical advice if necessary. In case of swallowing: Rinse the patient's mouth with water and drink water. Keep it calm. Do not induce vomiting. Call your local Toxication Center and get medical help.

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

Take some Antibacterial gel in your hand. Rub your hands, between the fingers, all the inner and outer surfaces, the nails, until they dry. It is used for hand cleaning. Do not rinse after use.

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, Carbomer, purified water USP, Triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 86815-002-04

1000 ML1000 ML

2500 mL NDC: 86815-002-05

2500 ML2500 ML

500 mL NDC: 86815-002-01

500 ML500 ML

100 mL NDC: 86815-002-02

100 ML100 ML

200 mL NDC: 86815-002-03

200 ML200 ML

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
86815-002-012025-01-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-022025-01-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-032025-01-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-042025-01-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-052025-01-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-012024-08-13C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-022024-08-13C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-032024-08-13C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-042024-08-13C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-052024-08-13C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-012024-07-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-022024-07-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-032024-07-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-042024-07-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-052024-07-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-012024-01-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-022024-01-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-032024-01-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-042024-01-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-052024-01-30C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-012022-02-01C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-022022-02-01C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-032022-02-01C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-042022-02-01C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-052022-02-01C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-012022-01-28C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-022022-01-28C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-032022-01-28C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-042022-01-28C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL
86815-002-052022-01-28C16284748780-1d6a99b39-dcd2-a426-e053-dadaa90af4c2DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86815-002DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL (ALCOHOL) GEL [AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI]9Legacy NDC20220201_a78faa3a-466e-81b6-e053-2995a90a3233.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86815-00286815-002-04, 86815-002-05, 86815-002-01, 86815-002-02, 86815-002-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
d64741db-01c4-3382-e053-2a95a90a4648a78faa3a-466e-81b6-e053-2995a90a32332022-01-23WarningsExact identifier
spl id: d64741db-01c4-3382-e053-2a95a90a4648
spl set id: a78faa3a-466e-81b6-e053-2995a90a3233

Reported adverse events (FAERS/openFDA)#

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