FDA.reportPublic FDA data

Hand Sanitizer wipes

Manufacturer
ORGANIKISIMO SA DE CV
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:34:31

Label at a glance#

ProductHand Sanitizer wipes
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

. Rub hands together until dry. disponse properly. Supervise children under 6 years of age when using this product.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer wipes

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer wipes 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. Keep away from heat or flame

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 keep out of eyes, ears, and mouth. 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

  • . Rub hands together until dry. disponse properly.
  • Supervise children under 6 years of age when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water,Glycerin, Polyethylene glycol, Isopropyl myristate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

210 ML NDC 79337-158-01 wipes bottlewipes bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489307ethanol 70 % Medicated PadPSN3
1489307ethanol 0.7 ML/ML Medicated PadSCD3
1489307ethanol 70 % Medicated PadSY3
1489307ethanol 70 % Medicated WipesSY3
1489307ethyl alcohol 70 % ClothSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79337-158-012022-01-28C16284748780-1d6a99b39-e6f3-a426-e053-dadaa90af4c2HAND SANITIZER WIPES BOTTLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79337-158-01Hand Sanitizer wipes210 mL in 1 BOTTLECLOTH2103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79337-158HAND SANITIZER WIPES (ETHYL ALCOHOL) CLOTH [ORGANIKISIMO SA DE CV]3Legacy NDC, 1 package rows20201203_ab979f2f-d48b-2801-e053-2995a90ab8d0.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79337-15879337-158-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
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
b5831377-9798-efa2-e053-2995a90a1e24ab979f2f-d48b-2801-e053-2995a90ab8d02020-12-02WarningsExact identifier
spl id: b5831377-9798-efa2-e053-2995a90a1e24
spl set id: ab979f2f-d48b-2801-e053-2995a90ab8d0

Reported adverse events (FAERS/openFDA)#

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