FDA.reportPublic FDA data

SAUBER KARE 500ml

Manufacturer
SSN Solutions LLC | Korea Medicare Co., Ltd.
Effective date
2020-10-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:13:31

Label at a glance#

ProductSAUBER KARE 500ml
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

OTC - ACTIVE INGREDIENT SECTION

Ethanol 70%

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

OTC - PURPOSE SECTION

Antibacterial

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product

avoid contact with 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 (1-800-222-1222) 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Carbomer, Triethanol Amine, Aloe extract, Lemon oil, Purified water.

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 (1-800-222-1222) right away.

SAUBER KARE 500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label ssnlabel ssn

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80704-10080704-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 934Z135WT9208IACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
LEMON OILI9GRO824LLIACT
ALOEV5VD430YW9IACT

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
b11ec687-728e-189f-e053-2a95a90af078b0b6c8ae-8d68-66b5-e053-2995a90a260f2020-10-07WarningsExact identifier
spl set id: b0b6c8ae-8d68-66b5-e053-2995a90a260f

Reported adverse events (FAERS/openFDA)#

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