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LARAMED Antibacterial Alcohol Wipes

Manufacturer
LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI
Effective date
2020-10-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:31:25

Label at a glance#

ProductLARAMED Antibacterial Alcohol Wipes
Active ingredientALCOHOL, ISOPROPYL ALCOHOL, BENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Open package, removeonewetwipetocleanyourhands| and body. Reseal, keep closed to prevent evaporation. 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 below 110F ( 43 C) Avoid freezing and excessive heat above 40C (104F) May discolor certain fabrics or surface.

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) (65%, weight/weight (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Isopropanol 10%, (w/w)
  3. Benzalkonium Chloride 0.05%, (w/w)
  4. Glycerol
  5. Tocopherol
  6. 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 65% w/w. Purpose: Antiseptic

Isopropanol 10% w/w. Purpose: Antiseptic

Benzalkonium chloride 0.05% w/w. 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 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

  • Open package, removeonewetwipetocleanyourhands| and body. Reseal, keep closed to prevent evaporation. 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 below 110F ( 43 C)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor certain fabrics or surface.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerol
Tocopherol

purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

120 pcs120 pcs

150 pcs150 pcs

70 pcs70 pcs

50 pcs50 pcs

15 pcs15 pcs

1 pcs1 pcs

100 pcs100 pcs

200 pcs200 pcs

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2398387benzalkonium chloride 0.05 % / ethanol 65 % / isopropyl alcohol 10 % Medicated PadPSN2
2398387benzalkonium chloride 0.5 MG/ML / ethanol 0.65 ML/ML / isopropyl alcohol 0.1 ML/ML Medicated PadSCD2
2398387benzalkonium chloride 0.05 % / ethanol 65 % / isopropyl alcohol 10 % Medicated PadSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
86994-007-182022-01-28C16284748780-1d6a99b39-cab0-a426-e053-dadaa90af4c2LARAMED ANTIBACTERIAL ALCOHOL WIPES
86994-007-202022-01-28C16284748780-1d6a99b39-cab0-a426-e053-dadaa90af4c2LARAMED ANTIBACTERIAL ALCOHOL WIPES
86994-007-222022-01-28C16284748780-1d6a99b39-cab0-a426-e053-dadaa90af4c2LARAMED ANTIBACTERIAL ALCOHOL WIPES
86994-007-242022-01-28C16284748780-1d6a99b39-cab0-a426-e053-dadaa90af4c2LARAMED ANTIBACTERIAL ALCOHOL WIPES
86994-007-262022-01-28C16284748780-1d6a99b39-cab0-a426-e053-dadaa90af4c2LARAMED ANTIBACTERIAL ALCOHOL WIPES
86994-007-282022-01-28C16284748780-1d6a99b39-cab0-a426-e053-dadaa90af4c2LARAMED ANTIBACTERIAL ALCOHOL WIPES
86994-007-302022-01-28C16284748780-1d6a99b39-cab0-a426-e053-dadaa90af4c2LARAMED ANTIBACTERIAL ALCOHOL WIPES
86994-007-322022-01-28C16284748780-1d6a99b39-cab0-a426-e053-dadaa90af4c2LARAMED ANTIBACTERIAL ALCOHOL WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86994-007-17LARAMED Antibacterial Alcohol Wipes648.8 g in 1 PATCHCLOTH648.82
86994-007-18LARAMED Antibacterial Alcohol Wipes200 in 1 PACKAGECLOTH2002
86994-007-19LARAMED Antibacterial Alcohol Wipes486.6 g in 1 PATCHCLOTH486.62
86994-007-20LARAMED Antibacterial Alcohol Wipes150 in 1 PACKAGECLOTH1502
86994-007-21LARAMED Antibacterial Alcohol Wipes389.28 g in 1 PATCHCLOTH389.282
86994-007-22LARAMED Antibacterial Alcohol Wipes120 in 1 PACKAGECLOTH1202
86994-007-23LARAMED Antibacterial Alcohol Wipes324.4 g in 1 PATCHCLOTH324.42
86994-007-24LARAMED Antibacterial Alcohol Wipes100 in 1 PACKAGECLOTH1002
86994-007-25LARAMED Antibacterial Alcohol Wipes227.08 g in 1 PATCHCLOTH227.082
86994-007-26LARAMED Antibacterial Alcohol Wipes70 in 1 PACKAGECLOTH702
86994-007-27LARAMED Antibacterial Alcohol Wipes162.2 g in 1 PATCHCLOTH162.22
86994-007-28LARAMED Antibacterial Alcohol Wipes50 in 1 PACKAGECLOTH502
86994-007-29LARAMED Antibacterial Alcohol Wipes48.66 g in 1 PATCHCLOTH48.662
86994-007-30LARAMED Antibacterial Alcohol Wipes15 in 1 PACKAGECLOTH152
86994-007-31LARAMED Antibacterial Alcohol Wipes3.244 g in 1 PATCHCLOTH3.2442
86994-007-32LARAMED Antibacterial Alcohol Wipes1 in 1 PACKAGECLOTH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86994-007LARAMED ANTIBACTERIAL ALCOHOL WIPES (ALCOHOL, ISOPROPANOL, BENZALKONIUM CHLORIDE) CLOTH [LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI]2Legacy NDC, 16 package rows20201012_b0d7b456-7550-a11f-e053-2a95a90a866a.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
86994-00786994-007-31, 86994-007-32, 86994-007-29, 86994-007-30, 86994-007-27, 86994-007-28, 86994-007-25, 86994-007-26, 86994-007-23, 86994-007-24, 86994-007-21, 86994-007-22, 86994-007-19, 86994-007-20, 86994-007-17, 86994-007-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ISOPROPYL ALCOHOLND2M416302ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
b162ebea-5c52-47d2-e053-2995a90ae152b0d7b456-7550-a11f-e053-2a95a90a866a2020-10-11WarningsExact identifier
spl id: b162ebea-5c52-47d2-e053-2995a90ae152
spl set id: b0d7b456-7550-a11f-e053-2a95a90a866a

Reported adverse events (FAERS/openFDA)#

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