FDA.reportPublic FDA data

Xtreme Hand Sanitizer Gel

Manufacturer
Xtreme Personal Care Inc
Effective date
2022-01-07
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:46:29

Label at a glance#

ProductXtreme Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Apply to hands/skin, rub until dry.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

For External Use Only. Flammable.

OTC - WHEN USING SECTION

Keep away from flames.  Keep out of eyes.  In case of contact with eyes, rinse eyes thoroughly with water.  Avoid contact with broken skin.  Do not inhale or ingest.

OTC - STOP USE SECTION

Stop use and contact a doctor if irritation develops or persists for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get immediate help or contact a poison control center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply to hands/skin, rub until dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Fragrance (Parfum), Triethanolamine, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A)

​Package Labeling: 74851-001-60

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60mL60mL

​Package Labeling: 74851-001-23

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

237mL237mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74851-001-232025-11-13C16284748780-10191ceaa-6649-198a-e063-dbdaa90aec3eXtreme Hand Sanitizer Gel
74851-001-602025-11-13C16284748780-10191ceaa-6649-198a-e063-dbdaa90aec3eXtreme Hand Sanitizer Gel
74851-001-232023-07-28C16284748780-10191ceaa-6649-198a-e063-dbdaa90aec3eXtreme Hand Sanitizer Gel
74851-001-602023-07-28C16284748780-10191ceaa-6649-198a-e063-dbdaa90aec3eXtreme Hand Sanitizer Gel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74851-001XTREME HAND SANITIZER (ALCOHOL) GEL [XTREME PERSONAL CARE INC]7Legacy NDC20220108_ae4f565a-26fb-4b1d-a9c6-944bdbba5d3c.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74851-00174851-001-60, 74851-001-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
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
f3a52a0b-267f-5b1d-e053-2995a90a7124ae4f565a-26fb-4b1d-a9c6-944bdbba5d3c2023-02-01WarningsExact identifier
spl set id: ae4f565a-26fb-4b1d-a9c6-944bdbba5d3c

Reported adverse events (FAERS/openFDA)#

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