FDA.reportPublic FDA data

4 Your Safety Hand Sanitizer

Manufacturer
Montenegro Castro, Carlos
Effective date
2020-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:33

Label at a glance#

Product4 Your Safety Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

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. 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

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Carbomer,Purified Water USP

Package Labeling:79252-000-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:79252-000-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling:79252-000-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Package Labeling:79252-000-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79252-000-012022-01-28C16284748780-1d6a99b39-5bdd-a426-e053-dadaa90af4c24 Your Safety Hand Sanitizer
79252-000-032022-01-28C16284748780-1d6a99b39-5bdd-a426-e053-dadaa90af4c24 Your Safety Hand Sanitizer
79252-000-042022-01-28C16284748780-1d6a99b39-5bdd-a426-e053-dadaa90af4c24 Your Safety Hand Sanitizer

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
79252-00079252-000-04, 79252-000-03, 79252-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
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
a93e36c4-f0f8-a16b-e053-2995a90a5e84c0378919-de89-4c4b-8300-caaf1fd494242020-06-29WarningsExact identifier
spl id: a93e36c4-f0f8-a16b-e053-2995a90a5e84
spl set id: c0378919-de89-4c4b-8300-caaf1fd49424

Reported adverse events (FAERS/openFDA)#

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