FDA.reportPublic FDA data

LARAMED Antibacterial Hand Sanitizer Gel

Manufacturer
LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI
Effective date
2020-10-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:31:27

Label at a glance#

ProductLARAMED Antibacterial Hand Sanitizer Gel
Active ingredientISOPROPYL ALCOHOL, ALCOHOL
Label structure13 sections

Dosage and administration

Place enough product in your palm to cover hands and rub hands together briskly until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 110F (43 C ) Avoid freezing and excessive heat above 40C (104F) May discolor certain fabrics or surface. Ethyl Alcohol % 70 Porpan-2-ol %10 Non sterile topical solution

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 (w/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Propan-2-ol (10% w/v).
  3. Glycerin
  4. Aloe vera extract
  5. Carbomer
  6. Triethanolamine
  7. 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 (ethanol)(70%, volume/volume (w/v))
Propan-2-ol (10% w/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 liquid and vapor.

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 do not use in or near the eyes. 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 in your palm to cover hands and rub hands together briskly until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 110F (43 C )
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor certain fabrics or surface.
  • Ethyl Alcohol % 70
  • Porpan-2-ol %10
  • Non sterile topical solution

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin
Aloe vera extract
Carbomer
Triethanolamine
water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50ml50ml800ml800ml250ml250ml300ml300ml5000ml5000ml500ml500ml100ml100ml10000ml10000ml150ml150ml1000ml1000ml400ml400ml200ml200ml50000ml50000ml750ml750ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2397131ethanol 70 % / isopropyl alcohol 10 % Topical GelPSN3
2397131ethanol 0.7 ML/ML / isopropyl alcohol 0.1 ML/ML Topical GelSCD3
2397131ethanol 70 % / isopropyl alcohol 10 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
86994-008-012022-01-28C16284748780-1d6a99b39-fcf3-a426-e053-dadaa90af4c2LARAMED Antibacterial Hand Sanitizer Gel
86994-008-022022-01-28C16284748780-1d6a99b39-fcf3-a426-e053-dadaa90af4c2LARAMED Antibacterial Hand Sanitizer Gel
86994-008-032022-01-28C16284748780-1d6a99b39-fcf3-a426-e053-dadaa90af4c2LARAMED Antibacterial Hand Sanitizer Gel
86994-008-042022-01-28C16284748780-1d6a99b39-fcf3-a426-e053-dadaa90af4c2LARAMED Antibacterial Hand Sanitizer Gel
86994-008-062022-01-28C16284748780-1d6a99b39-fcf3-a426-e053-dadaa90af4c2LARAMED Antibacterial Hand Sanitizer Gel
86994-008-072022-01-28C16284748780-1d6a99b39-fcf3-a426-e053-dadaa90af4c2LARAMED Antibacterial Hand Sanitizer Gel
86994-008-082022-01-28C16284748780-1d6a99b39-fcf3-a426-e053-dadaa90af4c2LARAMED Antibacterial Hand Sanitizer Gel
86994-008-092022-01-28C16284748780-1d6a99b39-fcf3-a426-e053-dadaa90af4c2LARAMED Antibacterial Hand Sanitizer Gel
86994-008-132022-01-28C16284748780-1d6a99b39-fcf3-a426-e053-dadaa90af4c2LARAMED Antibacterial Hand Sanitizer Gel
86994-008-152022-01-28C16284748780-1d6a99b39-fcf3-a426-e053-dadaa90af4c2LARAMED Antibacterial Hand Sanitizer Gel
86994-008-162022-01-28C16284748780-1d6a99b39-fcf3-a426-e053-dadaa90af4c2LARAMED Antibacterial Hand Sanitizer Gel
86994-008-172022-01-28C16284748780-1d6a99b39-fcf3-a426-e053-dadaa90af4c2LARAMED Antibacterial Hand Sanitizer Gel
86994-008-182022-01-28C16284748780-1d6a99b39-fcf3-a426-e053-dadaa90af4c2LARAMED Antibacterial Hand Sanitizer Gel
86994-008-192022-01-28C16284748780-1d6a99b39-fcf3-a426-e053-dadaa90af4c2LARAMED Antibacterial Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86994-008-01LARAMED Antibacterial Hand Sanitizer Gel5000 mL in 1 BOTTLE, PLASTICGEL50003
86994-008-02LARAMED Antibacterial Hand Sanitizer Gel10000 mL in 1 BOTTLE, PLASTICGEL100003
86994-008-03LARAMED Antibacterial Hand Sanitizer Gel50000 mL in 1 BOTTLE, PLASTICGEL500003
86994-008-04LARAMED Antibacterial Hand Sanitizer Gel1000 mL in 1 BOTTLE, PLASTICGEL10003
86994-008-06LARAMED Antibacterial Hand Sanitizer Gel750 mL in 1 BOTTLE, PLASTICGEL7503
86994-008-07LARAMED Antibacterial Hand Sanitizer Gel500 mL in 1 BOTTLE, PLASTICGEL5003
86994-008-08LARAMED Antibacterial Hand Sanitizer Gel400 mL in 1 BOTTLE, PLASTICGEL4003
86994-008-09LARAMED Antibacterial Hand Sanitizer Gel300 mL in 1 BOTTLE, PLASTICGEL3003
86994-008-13LARAMED Antibacterial Hand Sanitizer Gel100 mL in 1 BOTTLE, PLASTICGEL1003
86994-008-15LARAMED Antibacterial Hand Sanitizer Gel50 mL in 1 BOTTLE, PLASTICGEL503
86994-008-16LARAMED Antibacterial Hand Sanitizer Gel150 mL in 1 BOTTLE, PLASTICGEL1503
86994-008-17LARAMED Antibacterial Hand Sanitizer Gel200 mL in 1 BOTTLE, PLASTICGEL2003
86994-008-18LARAMED Antibacterial Hand Sanitizer Gel250 mL in 1 BOTTLE, PLASTICGEL2503
86994-008-19LARAMED Antibacterial Hand Sanitizer Gel800 mL in 1 BOTTLE, PLASTICGEL8003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86994-008LARAMED ANTIBACTERIAL HAND SANITIZER GEL (ETHYL ALCOHOL, PROPAN-2-OL) GEL [LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI]3Legacy NDC, 14 package rows20201013_af9c8daa-24e8-df28-e053-2995a90a4e57.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
86994-00886994-008-01, 86994-008-02, 86994-008-03, 86994-008-04, 86994-008-13, 86994-008-06, 86994-008-07, 86994-008-08, 86994-008-09, 86994-008-15, 86994-008-16, 86994-008-17, 86994-008-18, 86994-008-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
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
b178e08e-0f5f-3408-e053-2a95a90a7b1daf9c8daa-24e8-df28-e053-2995a90a4e572020-10-12WarningsExact identifier
spl id: b178e08e-0f5f-3408-e053-2a95a90a7b1d
spl set id: af9c8daa-24e8-df28-e053-2995a90a4e57

Reported adverse events (FAERS/openFDA)#

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