Ex- Gel Hand Sanitizer

Manufacturer
Sauber Halten, S.A. de C.V.
Effective date
2020-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:20

Label at a glance#

ProductSauber Halten SA de CV
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Uses * Hand Sanitizer helps eliminate bacteria on hands. Antiseptic hand sanitizer

Dosage and administration

Directions: Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Alcohol Denat 68%............ Antibacterial

Uses

INDICATIONS & USAGE SECTION

Uses

* Hand Sanitizer helps eliminate bacteria on hands. Antiseptic hand sanitizer

Warnings

WARNINGS SECTION

  • For external use only

When using this product avoid contact with eyes. In case of contact, flush with water for
several minutes.

  • Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control

Center right away.

  • Flammable: Keep away from heat and flame. Highly flammable liquid and vapor.
  • Stop use and ask Doctor: if skin irritation develops when using this product.
  • Do not inhale or ingest. Avoid contact with broken or damaged skin.

In case of accidental ingestion seek professional assistance or contact a Poison Control
Center immediately.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

* Irritation develops while using this product

Keep out of reach of children

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

  • Directions: Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin

Questions?

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS: Atention from 8.00 to 17.00 hours.


Tel: +52.55.5534.3611, 55.5534.3593 / 800.728.2371 www.sauberhalten.com


Calle del Pozo núm.15 Fracc. Las Cabañas. ZIP. 54658 Tepotzotlán, Edo. de México.

Uses

OTC - PURPOSE SECTION

Uses

* Hand Sanitizer helps eliminate bacteria on hands. Antiseptic hand sanitizer

Hand Sanitizer Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product labelProduct labelAntiseptic Hand Sanitizer Gel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76773-001-012021-07-23C16284748780-1c7ccaba7-13c8-fd44-e053-dadaa90aa01bEx- Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76773-001-01Sauber Halten SA de CV998 mL in 1 BOTTLE, WITH APPLICATORGEL9981

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76773-001SAUBER HALTEN SA DE CV (ALCOHOL) GEL [SAUBER HALTEN, S.A. DE C.V.]1Legacy NDC, 1 package rows20200428_a44a2fef-ea05-87e4-e053-2a95a90af1b1.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76773-00176773-001-01

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
GLYCERINPDC6A3C0OXIACT
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
a44a0d2c-4b0b-15fa-e053-2a95a90a2af8a44a2fef-ea05-87e4-e053-2a95a90af1b12020-04-27WarningsExact identifier
spl id: a44a0d2c-4b0b-15fa-e053-2a95a90a2af8
spl set id: a44a2fef-ea05-87e4-e053-2a95a90af1b1

Reported adverse events (FAERS/openFDA)#

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