FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Monarch Global Brands, Inc.
Effective date
2020-08-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:14

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product in your palm to cover your hands Rub hands together briskly until dry Children under 6 years of age should be supervised when using this product

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% v/v. Purpose: Antibacterial

Purpose

OTC - PURPOSE SECTION

Antibacterial, Hand Sanitizer

Use[s]

INDICATIONS & USAGE SECTION

  • Hand Sanitizer to reduce bacteria on the skin
  • Recommended for repeated use

Warnings

WARNINGS SECTION

Flammable., keep away from fire and flame

For external use only

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes. If contact occurs, rinse thoroughly with water.

Stop use and consult doctor

OTC - STOP USE SECTION

if irritation occurs or rash appears and lasts.

Keep out of reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or call a Poison Control Center.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to cover your hands
  • Rub hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product

Other information

OTHER SAFETY INFORMATION

  • Store below 106F (41C)
  • May discolor certain fabrics or surfaces
  • Avoid freezing and heat above 105F (40C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin，triethanolamine,carbomer, Aloe Barbadensis Leaf extract, Tocopheryl Acetate

Questions or Comments?

OTC - QUESTIONS SECTION

215 482 6100

info@monarchbrands.com

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

237mL NDC: 80330-007-01

Papillon

HAND SANITIZER

WITH ALOE

62% ETHYL

ALCOHOL

CDC RECOMENDED

FORMULA

ETHYL ALCOHOL ANTISEPTIC

TOPICAL SOLUTION

8 oz. (237ml)

PDPPDP

355mL NDC: 80330-007-02

Papillon

HAND SANITIZER

WITH ALOE

62% ETHYL

ALCOHOL

CDC RECOMENDED

FORMULA

ETHYL ALCOHOL ANTISEPTIC

TOPICAL SOLUTION

12 oz. (355ml)

PDPPDP

3785mL NDC: 80330-007-03

Papillon

HAND SANITIZER

WITH ALOE

62% ETHYL

ALCOHOL

CDC RECOMENDED

FORMULA

ETHYL ALCOHOL ANTISEPTIC

TOPICAL SOLUTION

1 U.S. Gallon

PDPPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80330-001-012022-01-28C16284748780-1d6a99b39-aed3-a426-e053-dadaa90af4c2Hand Sanitizer
80330-001-022022-01-28C16284748780-1d6a99b39-aed3-a426-e053-dadaa90af4c2Hand Sanitizer
80330-001-032022-01-28C16284748780-1d6a99b39-aed3-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80330-001-01Hand Sanitizer237 mL in 1 BOTTLEGEL2371
80330-001-02Hand Sanitizer355 mL in 1 BOTTLEGEL3551
80330-001-03Hand Sanitizer3785 mL in 1 BOTTLEGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80330-001HAND SANITIZER (ALCOHOL) GEL [MONARCH GLOBAL BRANDS, INC.]1Legacy NDC, 3 package rows20200829_adea8ad3-d476-07a0-e053-2a95a90a1799.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
80330-00180330-001-01, 80330-001-02, 80330-001-03
74742-007

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT

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
adeaad60-8e5e-7482-e053-2995a90ac688adea8ad3-d476-07a0-e053-2a95a90a17992020-08-27WarningsExact identifier
spl id: adeaad60-8e5e-7482-e053-2995a90ac688
spl set id: adea8ad3-d476-07a0-e053-2a95a90a1799

Reported adverse events (FAERS/openFDA)#

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