FDA.reportPublic FDA data

Iconic Medical Group Hand Sanitizer - 12oz

Manufacturer
Forsythe Cosmetic Group, Ltd.
Effective date
2020-04-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:44

Label at a glance#

ProductIconic Medical Group Hand Sanitizer - 12oz 12oz
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

354.882mL NDC: 76909-0001-1

  • Place enough product on hands to cover all surfaces
  • Rub hands until dry
  • Supervise children under 6 years of age when using this product DOSAGE & ADMINISTRATION SECTION FOUND WITHINDOSAGE & ADMINISTRATION SECTION FOUND WITHIN

WARNINGS SECTION

354.882mL NDC: 76909-0001-1

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

INACTIVE INGREDIENT SECTION

354.882mL NDC: 76909-0001-1

INACTIVE INGREDIENTS: glycerin, hydrogen peroxide, xanthum gum, distilled water INACTIVE INGREDIENTSINACTIVE INGREDIENTS

INDICATIONS & USAGE SECTION

354.882mL NDC: 76909-0001-1

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

Indications & Usage SectionIndications & Usage Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

354.882mL NDC: 76909-0001-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTIONOTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - PURPOSE SECTION

354.882mL NDC: 76909-0001-1

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

OTC - PURPOSE SECTIONOTC - PURPOSE SECTION

OTC - ACTIVE INGREDIENT SECTION

354.882mL NDC: 76909-0001-1

ACTIVE INGREDIENT(S)

Ethanol 75% v/v.................................Antiseptic

OTC - ACTIVE INGREDIENTS SECTIONOTC - ACTIVE INGREDIENTS SECTION

Full Bottle Label - 12oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

354.882mL NDC: 76909-0001-1 12oz / 354.882mL Label12oz / 354.882mL Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76909-0001-12022-01-28C16284748780-1d6a99b39-5786-a426-e053-dadaa90af4c2a45e4bc8-2f25-130c-e053-2a95a90ac167

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76909-0001-1Iconic Medical Group Hand Sanitizer - 12oz12oz354.882 mL in 1 BOTTLEGEL354.8821

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76909-0001ICONIC MEDICAL GROUP HAND SANITIZER - 12OZ 12OZ (HAND SANITIZER) GEL [FORSYTHE COSMETIC GROUP, LTD.]1Legacy NDC, 1 package rows20200506_a45e4bc8-2f25-130c-e053-2a95a90ac167.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76909-000176909-0001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
ALCOHOL3K9958V90MACTIB
HYDROGEN PEROXIDEBBX060AN9VIACT
GLYCERINPDC6A3C0OXIACT

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
a45e4bc8-2f26-130c-e053-2a95a90ac167a45e4bc8-2f25-130c-e053-2a95a90ac1672020-04-28WarningsExact identifier
spl id: a45e4bc8-2f26-130c-e053-2a95a90ac167
spl set id: a45e4bc8-2f25-130c-e053-2a95a90ac167

Reported adverse events (FAERS/openFDA)#

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