ISM BE-YOU-TIFUL SELF CARE STUDIO

Manufacturer
HORIZON GROUP USA, INC.
Effective date
2020-10-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:11

Label at a glance#

ProductISM BE-YOU-TIFUL SELF CARE STUDIO
Active ingredientALCOHOL
Label structure9 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 Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol

Purpose

OTC - PURPOSE SECTION

Antiseptic

Warnings

WARNINGS SECTION

  • For external use only. Flammable. Keep away from heat or flame.
  • Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
  • Do not use in children less than 2 months of age; on open skin wounds
  • When using this product keep out of 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.

Uses

INDICATIONS & USAGE SECTION

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

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away.

Other Information 

SPL UNCLASSIFIED SECTION

Store between 15-30C (59-86F); Avoid freezing or excessive heat above 40C (104F)

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau,Glycerin,Carbomer,Triethanolamine,parfum,Denatonium benzoate,Red 27 (CI 45410).

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80797-001-012022-01-28C16284748780-1d6a99b39-e2d0-a426-e053-dadaa90af4c2ISM BE-YOU-TIFUL SELF CARE STUDIO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80797-001-01ISM BE-YOU-TIFUL SELF CARE STUDIO28 mL in 1 BOTTLEGEL281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80797-001ISM BE-YOU-TIFUL SELF CARE STUDIO (ETHYL ALCOHOL) GEL [HORIZON GROUP USA, INC.]1Legacy NDC, 1 package rows20201008_e54cb90a-29fd-4d5c-ad59-5a2fa3eab5f9.zip

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
80797-00180797-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
e25a27d9-a5f8-4525-a428-295aa41819cfe54cb90a-29fd-4d5c-ad59-5a2fa3eab5f92020-10-07WarningsExact identifier
spl id: e25a27d9-a5f8-4525-a428-295aa41819cf
spl set id: e54cb90a-29fd-4d5c-ad59-5a2fa3eab5f9

Reported adverse events (FAERS/openFDA)#

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