FDA.reportPublic FDA data

hand sanitizer gel

Manufacturer
the california spirits company
Effective date
2020-06-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:17:03

Label at a glance#

Producthand sanitizer gel
Active ingredientALCOHOL
Label structure12 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

SD Alcohol 70% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

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

  • 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.

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

Water, Glycerin, Propylene Glycol, Triethanolamine, Carbopol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77122-001-1077122-001-10NDC: 77122-001-10

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77122-001-002022-01-28C16284748780-1d6a99b39-5a86-a426-e053-dadaa90af4c2hand sanitizer gel
77122-001-012022-01-28C16284748780-1d6a99b39-5a86-a426-e053-dadaa90af4c2hand sanitizer gel
77122-001-022022-01-28C16284748780-1d6a99b39-5a86-a426-e053-dadaa90af4c2hand sanitizer gel
77122-001-042022-01-28C16284748780-1d6a99b39-5a86-a426-e053-dadaa90af4c2hand sanitizer gel
77122-001-052022-01-28C16284748780-1d6a99b39-5a86-a426-e053-dadaa90af4c2hand sanitizer gel
77122-001-062022-01-28C16284748780-1d6a99b39-5a86-a426-e053-dadaa90af4c2hand sanitizer gel
77122-001-082022-01-28C16284748780-1d6a99b39-5a86-a426-e053-dadaa90af4c2hand sanitizer gel
77122-001-092022-01-28C16284748780-1d6a99b39-5a86-a426-e053-dadaa90af4c2hand sanitizer gel
77122-001-102022-01-28C16284748780-1d6a99b39-5a86-a426-e053-dadaa90af4c2hand sanitizer gel
77122-001-122022-01-28C16284748780-1d6a99b39-5a86-a426-e053-dadaa90af4c2hand sanitizer gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77122-001-00hand sanitizer gel1022061 mL in 1 CONTAINERGEL10220614
77122-001-01hand sanitizer gel1 mL in 1 PACKETGEL14
77122-001-02hand sanitizer gel59.2 mL in 1 BOTTLE, PLASTICGEL59.24
77122-001-04hand sanitizer gel118.3 mL in 1 BOTTLE, PLASTICGEL118.34
77122-001-05hand sanitizer gel208198 mL in 1 DRUMGEL2081984
77122-001-06hand sanitizer gel177.4 mL in 1 BOTTLE, PLASTICGEL177.44
77122-001-08hand sanitizer gel236.6 mL in 1 BOTTLE, PLASTICGEL236.64
77122-001-09hand sanitizer gel473.2 mL in 1 BOTTLE, PLASTICGEL473.24
77122-001-10hand sanitizer gel3785.4 mL in 1 BOTTLE, PLASTICGEL3785.44
77122-001-12hand sanitizer gel354 mL in 1 BOTTLE, PLASTICGEL3544

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77122-001HAND SANITIZER GEL (ETHYL ALCOHOL) GEL [THE CALIFORNIA SPIRITS COMPANY]4Legacy NDC, 10 package rows20200611_a5017256-ba84-79d3-e053-2995a90ac940.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
77122-00177122-001-04, 77122-001-06, 77122-001-02, 77122-001-01, 77122-001-08, 77122-001-09, 77122-001-10, 77122-001-12, 77122-001-00, 77122-001-05

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
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
a7c1648a-d394-3f12-e053-2a95a90ae4ffa5017256-ba84-79d3-e053-2995a90ac9402020-06-10WarningsExact identifier
spl id: a7c1648a-d394-3f12-e053-2a95a90ae4ff
spl set id: a5017256-ba84-79d3-e053-2995a90ac940

Reported adverse events (FAERS/openFDA)#

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