FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Saniklyn, S. de R.L. de M.I.
Effective date
2020-07-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:22:21

Label at a glance#

ProductTeem Hogar
Active ingredientALCOHOL
Label structure12 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.

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 72% v/v. 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. 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

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water USP, glycerine, triethalonamine and carbomer.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC: 79004-003-01 PDP 60 mlPDP 60 ml473 mL NDC: 79004-003-02 PDP 473 mlPDP 473 ml

1000 mL NDC: 79004-003-03 PDP 1000 mLPDP 1000 mL

3785 mL NDC: 79004-003-04 PDP 3785 mlPDP 3785 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2277550ethanol 72 % Topical GelPSN2
2277550ethanol 0.72 ML/ML Topical GelSCD2
2277550ethanol 72 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79004-004-022022-01-28C16284748780-1d6a99b39-ac30-a426-e053-dadaa90af4c2a9d14aa0-e499-322b-e053-2995a90af220
79004-004-032022-01-28C16284748780-1d6a99b39-ac30-a426-e053-dadaa90af4c2a9d14aa0-e499-322b-e053-2995a90af220
79004-004-042022-01-28C16284748780-1d6a99b39-ac30-a426-e053-dadaa90af4c2a9d14aa0-e499-322b-e053-2995a90af220
79004-004-052022-01-28C16284748780-1d6a99b39-ac30-a426-e053-dadaa90af4c2a9d14aa0-e499-322b-e053-2995a90af220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79004-004-02Teem Hogar473 mL in 1 BOTTLEGEL4732
79004-004-03Teem Hogar60 mL in 1 BOTTLEGEL602
79004-004-04Teem Hogar1000 mL in 1 BOTTLEGEL10002
79004-004-05Teem Hogar3785 mL in 1 BOTTLEGEL37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79004-004TEEM HOGAR (ALCOHOL) GEL [SANIKLYN, S. DE R.L. DE M.I.]2Legacy NDC, 4 package rows20200724_a9d14aa0-e499-322b-e053-2995a90af220.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79004-00479004-004-03, 79004-004-02, 79004-004-04, 79004-004-05

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
CARBOMER 1342809Y72KV36IACT
GLYCERINPDC6A3C0OXIACT
TRIETHANOLAMINE HYDRIODIDEDT98IT03JKIACT
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
ab129be6-04b2-224a-e053-2995a90a8cd9a9d14aa0-e499-322b-e053-2995a90af2202020-07-22WarningsExact identifier
spl id: ab129be6-04b2-224a-e053-2995a90a8cd9
spl set id: a9d14aa0-e499-322b-e053-2995a90af220

Reported adverse events (FAERS/openFDA)#

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