LARA MED Antibacterial Wet Wipes

Manufacturer
LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI
Effective date
2020-10-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:31:27

Label at a glance#

ProductLARA MED Antibacterial Wet Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Open package, remove one wet wipes to clean your hands 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 at room temparature. Do not flush down toilet.

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. Benzalkonium Chloride (USP or Food Chemical Codex (FCC) grade) (0.15%, weight/weight (w/w)) in an aqueous solution denatured Trade Bureau regulations in 27 CFR part 20
  2. ALLANTOIN,
  3. ALOE BARBADENSIS LEAF JUICE,
  4. BENZOIC ACID,
  5. CITRIC ACID,
  6. COCAMIDOPROPYL BETAINE,
  7. DEHYDROACETIC ACID,
  8. DICAPRYLYL CARBONATE,
  9. GLYCERIN,
  10. GLYCERYL OLEATE,
  11. LAURYL GLUCOSIDE,
  12. OLUS OIL,
  13. PANTHENOL,
  14. PARFUM,
  15. PHENOXYETHANOL,
  16. POLYGLYCERYL-2-DIPOLYHYDROXYSTEARATE,
  17. POLYSORBATE 20,
  18. PROPYLENE GLYCOL,
  19. 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

Benzalkonium Chloride 0.15% w/w. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Standard usage Antibacterial wet wipes; soak the closed and impermeable package inside hot water until it gets warm. Microwave usage: Heat the package at 750 W for seconds by lag label side openly.

Antibacterial Wet wipes: Whenever is necessary and needed, it can be used as 1 piece for patients to wipe.It is used to clean who is incontinent position in need bath.

Wet Wipe 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. 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
  • if you are allergic to chlorhexidine gluconate or any other ingredients.

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, sensitization or allergic reaction 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, remove one wet wipes to clean your hands 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 at room temparature.
  • Do not flush down toilet.

Inactive ingredients

INACTIVE INGREDIENT SECTION

ALLANTOIN, ALOE BARBADENSIS LEAF JUICE, BENZOIC ACID, CITRIC ACID, COCAMIDOPROPYL BETAINE, DEHYDROACETIC ACID, DICAPRYLYL CARBONATE, GLYCERIN, GLYCERYL OLEATE, LAURYL GLUCOSIDE, OLUS OIL, PANTHENOL, PARFUM, PHENOXYETHANOL, POLYGLYCERYL-2-DIPOLYHYDROXYSTEARATE, POLYSORBATE 20, PROPYLENE GLYCOL, WATER

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24 pcs24 pcs

120 pcs120 pcs

15 pcs15 pcs

80 pcs80 pcs

50 pcs50 pcs

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038559benzalkonium Cl 0.15 % Medicated PadPSN5
1038559benzalkonium chloride 1.5 MG/ML Medicated PadSCD5
1038559benzalkonium chloride 0.15 % Medicated ToweletteSY5
1038559benzalkonium chloride 0.15 % Topical SwabSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86994-004-06LARA MED Antibacterial Wet Wipes0.03285 g in 1 PATCHCLOTH0.032855
86994-004-07LARA MED Antibacterial Wet Wipes15 in 1 PACKAGECLOTH155
86994-004-08LARA MED Antibacterial Wet Wipes0.0139 g in 1 PATCHCLOTH0.01395
86994-004-09LARA MED Antibacterial Wet Wipes24 in 1 PACKAGECLOTH245
86994-004-10LARA MED Antibacterial Wet Wipes0.06885 g in 1 PATCHCLOTH0.068855
86994-004-11LARA MED Antibacterial Wet Wipes50 in 1 PACKAGECLOTH505
86994-004-12LARA MED Antibacterial Wet Wipes0.0552 g in 1 PATCHCLOTH0.05525
86994-004-13LARA MED Antibacterial Wet Wipes80 in 1 PACKAGECLOTH805
86994-004-14LARA MED Antibacterial Wet Wipes0.0552 g in 1 PATCHCLOTH0.05525
86994-004-15LARA MED Antibacterial Wet Wipes120 in 1 PACKAGECLOTH1205
86994-004-16LARA MED Antibacterial Wet Wipes0.0552 g in 1 PATCHCLOTH0.05525
86994-004-17LARA MED Antibacterial Wet Wipes100 in 1 PACKAGECLOTH1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86994-004LARA MED ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI]5Legacy NDC, 12 package rows20201013_a9e8ef10-d00c-b416-e053-2a95a90a77f8.zip

Products#

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

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NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
b16c27f4-f000-87a8-e053-2995a90a12b6a9e8ef10-d00c-b416-e053-2a95a90a77f82020-10-11WarningsExact identifier
spl id: b16c27f4-f000-87a8-e053-2995a90a12b6
spl set id: a9e8ef10-d00c-b416-e053-2a95a90a77f8

Reported adverse events (FAERS/openFDA)#

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