RFL Antiseptic Hand Sanitizer

Manufacturer
RFL AKVARYUM SISTEMLERI SANAYI VE TICARET LIMITED SIRKETI
Effective date
2022-01-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:50

Label at a glance#

ProductRFL Antiseptic Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

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) (78,5%, 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
  3. Aloe vera leaf juice
  4. 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 78,5% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

for hand washing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in the eyes.

OTC - WHEN USING SECTION



Stop use and ask a doctor if

-irritation and redness develop.

-condition persists for more than 72 hours.

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

  • Wet hands thoroughly with product and allow to dry without wiping.

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

aloe vera leaf juice, deionized water, glycerin.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 mL NDC: 86807-001-01

250 ml250 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2387549ethanol 78.5 % Topical SolutionPSN2
2387549ethanol 0.785 ML/ML Topical SolutionSCD2
2387549ethanol 78.5 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
86807-001-012024-01-30C16284748780-11030e365-4378-111a-e063-dadaa90a10e2RFL ANTISEPTIC HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86807-001-01RFL Antiseptic Hand Sanitizer250 mL in 1 BOTTLE, PLASTICLIQUID2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86807-001RFL ANTISEPTIC HAND SANITIZER (ALCOHOL) LIQUID [RFL AKVARYUM SISTEMLERI SANAYI VE TICARET LIMITED SIRKETI]2Legacy NDC, 1 package rows20220201_ac29c37b-1c61-6c1c-e053-2995a90a7246.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86807-00186807-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
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
d66827a1-fe7b-3857-e053-2a95a90ac876ac29c37b-1c61-6c1c-e053-2995a90a72462022-01-25WarningsExact identifier
spl id: d66827a1-fe7b-3857-e053-2a95a90ac876
spl set id: ac29c37b-1c61-6c1c-e053-2995a90a7246

Reported adverse events (FAERS/openFDA)#

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