FDA.reportPublic FDA data

Moisturizing Hand Sanitizer

Manufacturer
American Chemical LLC
Effective date
2020-09-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:29:51

Label at a glance#

ProductMoisturizing Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place a small amount in your palms and rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Do not store above 104° F (40° C)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% w/w. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • On children less than 2 months of age
  • On open skin wounds

OTC - WHEN USING SECTION

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place a small amount in your palms and rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Do not store above 104° F (40° C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Hydroxypropyl Cellulose, Cetyl Lactate, Natural Fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80375-00180375-001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80375-001-012022-01-28C16284748780-1d6a99b39-7c5b-a426-e053-dadaa90af4c2Moisturizing Hand Sanitizer
80375-001-022022-01-28C16284748780-1d6a99b39-7c5b-a426-e053-dadaa90af4c2Moisturizing Hand Sanitizer
80375-001-032022-01-28C16284748780-1d6a99b39-7c5b-a426-e053-dadaa90af4c2Moisturizing Hand Sanitizer
80375-001-042022-01-28C16284748780-1d6a99b39-7c5b-a426-e053-dadaa90af4c2Moisturizing Hand Sanitizer
80375-001-052022-01-28C16284748780-1d6a99b39-7c5b-a426-e053-dadaa90af4c2Moisturizing Hand Sanitizer
80375-001-062022-01-28C16284748780-1d6a99b39-7c5b-a426-e053-dadaa90af4c2Moisturizing Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80375-001-01Moisturizing Hand Sanitizer3260.6 g in 1 BOTTLE, PLASTICGEL3260.62
80375-001-02Moisturizing Hand Sanitizer861362 g in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL8613622
80375-001-03Moisturizing Hand Sanitizer293.7 g in 1 BOTTLE, PLASTICGEL293.72
80375-001-04Moisturizing Hand Sanitizer391.6 g in 1 BOTTLE, PLASTICGEL391.62
80375-001-05Moisturizing Hand Sanitizer97.85 g in 1 BOTTLE, PLASTICGEL97.852
80375-001-06Moisturizing Hand Sanitizer24.43 g in 1 BOTTLEGEL24.432

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80375-001MOISTURIZING HAND SANITIZER (HAND SANITIZER) GEL [AMERICAN CHEMICAL LLC]2Legacy NDC, 6 package rows20200922_ae5c18c1-de29-06cd-e053-2a95a90a4491.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
80375-00180375-001-01, 80375-001-02, 80375-001-03, 80375-001-04, 80375-001-05, 80375-001-06

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
LIMONENE, (+)-GFD7C86Q1WIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
CETYL LACTATEA7EVH2RK4OIACT

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
afdb2fe0-c3a3-7184-e053-2a95a90ac6a3ae5c18c1-de29-06cd-e053-2a95a90a44912020-09-21WarningsExact identifier
spl id: afdb2fe0-c3a3-7184-e053-2a95a90ac6a3
spl set id: ae5c18c1-de29-06cd-e053-2a95a90a4491

Reported adverse events (FAERS/openFDA)#

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