LARA Hygiene Hand Skin Cleaner

Manufacturer
LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI
Effective date
2020-10-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:31:25

Label at a glance#

ProductLARA MED Antibacterial Hand Skin Cleaner
Active ingredientALCOHOL, ISOPROPYL ALCOHOL
Label structure13 sections

Dosage and administration

use 3 ml product in your palm and hands. Rubbed well for 30 seconds. Allow to dry without wiping. Discard properly after use. 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) Keep away sunlight. Pressurized container: Do not pierce or burn, even after use.

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) (60.7%, 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. Isopropyl Alcohol 8.7% (v/v)
  3. Glycerol (1.3% (v/v)
  4. BUTANE (3.25% (v/v)
  5. PROPANE (0.875% (v/v)
  6. ISOBUTANE (0.875% (v/v)
  7. FD&C Blue No.1 (0.0001% (v/v)
  8. 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 60.7% v/v. Purpose: Antiseptic

Isopropyl Alcohol 8.7% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

In order to maintain personel hygiene, it can be easily used in any environment that does not require soap without dilution.

For use when soap and water are not available. Ready to use. For use in examinations and clinics where surgical skin hygiene needed. For use before injection, and surgery and intensive care wherever hand and skin hygiene is required.

Warnings

WARNINGS SECTION

For external use only. If irritation occurs, discontinue use.

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, sensitization or allergin reaction 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.

Flammable Do not use while smoking or near heat or flame

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

  • use 3 ml product in your palm and hands. Rubbed well for 30 seconds. Allow to dry without wiping. Discard properly after use.
  • 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)
  • Keep away sunlight.
  • Pressurized container: Do not pierce or burn, even after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butane, Glycerol, Propane, Isobutane, FD&C Blue No.1, Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL NDC:86994-006-01

100 ml100 ml

86994-006-02 NDC - 150 ml

150ml150ml

86994-006-03 NDC - 300 ml

300 ml300 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2397709ethanol 60.7 % / isopropyl alcohol 8.7 % Topical SprayPSN4
2397709ethanol 0.607 ML/ML / isopropyl alcohol 0.087 ML/ML Topical SpraySCD4
2397709ethanol 60.7 % / isopropyl alcohol 8.7 % Topical SpraySY4

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86994-006-01LARA MED Antibacterial Hand Skin Cleaner100 mL in 1 BOTTLE, SPRAYAEROSOL, SPRAY1004
86994-006-02LARA MED Antibacterial Hand Skin Cleaner150 mL in 1 BOTTLE, SPRAYAEROSOL, SPRAY1504
86994-006-03LARA MED Antibacterial Hand Skin Cleaner300 mL in 1 BOTTLE, SPRAYAEROSOL, SPRAY3004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86994-006LARA MED ANTIBACTERIAL HAND SKIN CLEANER (ALCOHOL-ISOPROPYL ALCOHOL) AEROSOL, SPRAY [LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI]4Legacy NDC, 3 package rows20201012_ab72a082-e299-baf4-e053-2a95a90a6a89.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86994-00686994-006-01, 86994-006-02, 86994-006-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
b1630690-2d93-fa8a-e053-2995a90a383eab72a082-e299-baf4-e053-2a95a90a6a892020-10-11WarningsExact identifier
spl id: b1630690-2d93-fa8a-e053-2995a90a383e
spl set id: ab72a082-e299-baf4-e053-2a95a90a6a89

Reported adverse events (FAERS/openFDA)#

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