FDA.reportPublic FDA data

CREME 21 HAND SANITIZER

Manufacturer
Creme 21 GmbH | Helios Perfumes and Cosmetics LLC
Effective date
2021-10-22
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 22:31:02

Label at a glance#

ProductCREME 21 HAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ALCOHOL 65% v/v......... antimicrobial

OTC - DO NOT USE SECTION

Do not use

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of children. If swallowed, get medical help or contact a poison control centre right away.

INDICATIONS & USAGE SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.

OTHER SAFETY INFORMATION

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

WARNINGS SECTION

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

INACTIVE INGREDIENT SECTION

Aqua (water), Aloe barbadensis leaf extract, Carbomer, Fragrance, Glycerin, Melia azadirachta leaf extract, Polysorbate 20, Triethanolamine, Tocopherol.

OTC - PURPOSE SECTION

USES: Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are no available.

DOSAGE & ADMINISTRATION SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Creme 21 Hand sanitizer final labelCreme 21 Hand sanitizer final label

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73797-10073797-100-01, 73797-100-02, 73797-100-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
AZADIRACHTA INDICA LEAFHKY915780TIACT
POLYSORBATE 207T1F30V5YHIACT
TOCOPHEROLR0ZB2556P8IACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
ceed4e13-1b25-4ec9-e053-2995a90abcaea15bc7e4-c004-9cb7-e053-2995a90a86e72021-10-22WarningsExact identifier
spl id: ceed4e13-1b25-4ec9-e053-2995a90abcae
spl set id: a15bc7e4-c004-9cb7-e053-2995a90a86e7

Reported adverse events (FAERS/openFDA)#

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