FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
SWEET SEASONS LLC
Effective date
2020-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:19:55

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

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.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.5% v/v).
  3. Hydroxyethylcellulose (0.5% v/v).
  4. Sterile distilled water or boiled cold water.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in 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. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

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.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydroxyethylcellulose, purified water USP, fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

125 mL NDC: 76838-001-01

125125

500 mL NDC: 76838-001-02

500500

900 mL NDC: 76838-001-03

900900

3750mL NDC: 76838-001-04

37503750

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76838-001-012022-01-28C16284748780-1d6a99b39-aafe-a426-e053-dadaa90af4c2HAND SANITIZER
76838-001-022022-01-28C16284748780-1d6a99b39-aafe-a426-e053-dadaa90af4c2HAND SANITIZER
76838-001-032022-01-28C16284748780-1d6a99b39-aafe-a426-e053-dadaa90af4c2HAND SANITIZER
76838-001-042022-01-28C16284748780-1d6a99b39-aafe-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76838-001-01Hand Sanitizer125 mL in 1 BOTTLEGEL1252
76838-001-02Hand Sanitizer500 mL in 1 BOTTLEGEL5002
76838-001-03Hand Sanitizer900 mL in 1 BOTTLEGEL9002
76838-001-04Hand Sanitizer3750 mL in 1 BOTTLEGEL37502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76838-001HAND SANITIZER (ALCOHOL) GEL [SWEET SEASONS LLC]2Legacy NDC, 4 package rows20200703_a415ff55-95e2-697e-e053-2a95a90ae366.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76838-00176838-001-01, 76838-001-02, 76838-001-03, 76838-001-04

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
GLYCERINPDC6A3C0OXIACT
CETYL HYDROXYETHYLCELLULOSE (350000 MW)T7SWE4S2TTIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a97d4e69-4616-3110-e053-2995a90a0590a415ff55-95e2-697e-e053-2a95a90ae3662020-07-02WarningsExact identifier
spl id: a97d4e69-4616-3110-e053-2995a90a0590
spl set id: a415ff55-95e2-697e-e053-2a95a90ae366

Reported adverse events (FAERS/openFDA)#

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