FDA.reportPublic FDA data

Rael Clean Sanitizing Wipes

Manufacturer
Rael, Inc. | FIRSTCHAM CO., LTD
Effective date
2020-08-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:16:35

Label at a glance#

ProductRael Clean Sanitizing Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

Uses: Hand sanitizer to help reduce bacteria on skin

Dosage and administration

Directions: ■ Wet hands thoroughly with product and allow to dry without wiping ■ Discard wipes in trash receptacle after use ■ Do not flush

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Benzalkonium Chloride 0.1%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Water, Phenoxyethanol, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Tocopheryl acetate, Citric acid

PURPOSE

OTC - PURPOSE SECTION

Purpose: antiseptic

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 Posion Control Center right away

Uses

INDICATIONS & USAGE SECTION

Uses:

Hand sanitizer to help reduce bacteria on skin

WARNINGS

WARNINGS SECTION

Warnings


For external use only


Stop use and ask a doctor if irrigation or rash develops and continues for more than 72 hours


When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

■ Wet hands thoroughly with product and allow to dry without wiping

■ Discard wipes in trash receptacle after use
■ Do not flush

Other information

OTHER SAFETY INFORMATION

Other information:

■ Store in a cool dry place

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72863-001-012023-01-18C16284748780-1e4f33bdf-a47a-d8a0-e053-dadaa90a6e4e72863-001_Rael Clean Sanitizing Wipes
72863-001-022023-01-18C16284748780-1e4f33bdf-a47a-d8a0-e053-dadaa90a6e4e72863-001_Rael Clean Sanitizing Wipes
72863-001-032023-01-18C16284748780-1e4f33bdf-a47a-d8a0-e053-dadaa90a6e4e72863-001_Rael Clean Sanitizing Wipes
72863-001-012022-07-29C16284748780-1e4f33bdf-a47a-d8a0-e053-dadaa90a6e4e72863-001_Rael Clean Sanitizing Wipes
72863-001-022022-07-29C16284748780-1e4f33bdf-a47a-d8a0-e053-dadaa90a6e4e72863-001_Rael Clean Sanitizing Wipes
72863-001-032022-07-29C16284748780-1e4f33bdf-a47a-d8a0-e053-dadaa90a6e4e72863-001_Rael Clean Sanitizing Wipes

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72863-00172863-001-01, 72863-001-02, 72863-001-03

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
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
POLYSORBATE 207T1F30V5YHIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
f288d5fd-087a-5831-e053-2a95a90a8c596242d41e-0cf3-4559-9048-2ddfa19e84702023-01-18WarningsExact identifier
spl set id: 6242d41e-0cf3-4559-9048-2ddfa19e8470

Reported adverse events (FAERS/openFDA)#

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