LUBRIMA

Manufacturer
AGRO GRUP TEKNOLOJI BILGISAYAR SISTEMLERI TEMIZLIK MADDELERI SANAYI VE TICARET LIMITED SIR
Effective date
2020-09-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:35

Label at a glance#

ProductLUBRIMA ALCOHOL WET WIPES
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Open the cover of the wet wipes or seal the sticker. After use please close the wet wipes cover or seal the sticker to keep the wet wipes moist.        adults and children 12 years and over    Use as directed       children 6 years to under 12 years    Use as directed       children under 6 years    ask a doctor

Storage and handling

• store at 20-25° C (68-77° F) • protect from excessive moisture

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol (80%)

Purpose

OTC - PURPOSE SECTION

Hand Sanitizing

INDICATIONS & USAGE SECTION

Uses Do not use on eyes and mouth area, temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

   • glaucoma

   • a breathing problem such as emphysema or chronic bronchitis

Do NOT dispose in toilet to avoid clogging. Keep in cool place indoors avoid high temperature and direct sunlight. Do NOT throw on fire.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of unexpected symptoms, get medical help or contact a poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Open the cover of the wet wipes or seal the sticker. After use please close the wet wipes cover or seal the sticker to keep the wet wipes moist.

       adults and children 12 years and over   Use as directed
      children 6 years to under 12 years   Use as directed
      children under 6 years   ask a doctor

Other information

STORAGE AND HANDLING SECTION

• store at 20-25° C (68-77° F)
• protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerine

SPL UNCLASSIFIED SECTION

%80 ALCOHOL
FORMULATION SAFE FOR HANDS

ALCOHOL CONTENT %80

WARNING

After use please close the seal to prevent water evaporation. Discontinue use if there is any wound, redness, swelling or other discomfort. Wet wipes do not dissolve in water.

PRODUCT FEATURES

Super thick soft cotton touch for increased comfort. Reverse osmosis purified water removes impurities.

Consignor:
A-K Health LLC
520 Robinson LN Unit 4, Wilmington
19805 DE (Delaware)
+1 857 272 4139
EIN: 35-2643785

ISO

GMP

PRODUCT INFORMATION
Name of Commodity:
Hand wipes
Product Specification:
140mm x 200mm / 80 Pcs. / Net Weight: 425g / Gross Weight: 450g.
Name of Commodity:
Hand wipes
Manufacturer:
AGRO GRUP TEKNOLOJI LTD. STI.

Selimpasa Mah. 6093. sk. No: 86/1
Silivri / Istanbul - Türkiye
UBB Record Number:
0080856431
Man. Licence No:
27527096

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2361646ethanol 80 % Medicated PadPSN1
2361646ethanol 0.8 ML/ML Medicated PadSCD1
2361646ethanol 80 % Medicated WipesSY1
2361646ethyl alcohol 80 % Topical ClothSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80481-101-012022-01-28C16284748780-1d6a99b39-afe3-a426-e053-dadaa90af4c2​Lubrima ​ALCOHOL WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80481-101-01LUBRIMAALCOHOL WET WIPES80 in 1 CANISTERCLOTH801
80481-101-01LUBRIMAALCOHOL WET WIPES4.20 mL in 1 PACKAGECLOTH4.201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80481-101LUBRIMA ALCOHOL WET WIPES (ETHYL ALCOHOL) CLOTH [AGRO GRUP TEKNOLOJI BILGISAYAR SISTEMLERI TEMIZLIK MADDELERI SANAYI VE TICARET LIMITED SIR]1Legacy NDC, 2 package rows20200917_e40c6fe0-ec91-4856-b375-c0ffed4be83b.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
80481-10180481-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
315da0cb-a763-4be6-a874-d4dc14cc4fa0e40c6fe0-ec91-4856-b375-c0ffed4be83b2020-09-04WarningsExact identifier
spl id: 315da0cb-a763-4be6-a874-d4dc14cc4fa0
spl set id: e40c6fe0-ec91-4856-b375-c0ffed4be83b

Reported adverse events (FAERS/openFDA)#

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