FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Jewellery Time Limited
Effective date
2020-07-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:02

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

Hand Sanitizer

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

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, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77451-301-012022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-022022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-032022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-042022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-052022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-062022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-072022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-082022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-092022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-102022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-112022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-122022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-132022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-142022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-152022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-162022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-172022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-182022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-192022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer
77451-301-202022-01-28C16284748780-1d6a99b39-917a-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77451-301-01Hand Sanitizer30 mL in 1 BOTTLELIQUID301
77451-301-02Hand Sanitizer30 mL in 1 BOTTLELIQUID301
77451-301-03Hand Sanitizer100 mL in 1 BOTTLELIQUID1001
77451-301-04Hand Sanitizer100 mL in 1 BOTTLELIQUID1001
77451-301-05Hand Sanitizer120 mL in 1 BOTTLELIQUID1201
77451-301-06Hand Sanitizer120 mL in 1 BOTTLELIQUID1201
77451-301-07Hand Sanitizer300 mL in 1 BOTTLELIQUID3001
77451-301-08Hand Sanitizer300 mL in 1 BOTTLELIQUID3001
77451-301-09Hand Sanitizer500 mL in 1 BOTTLELIQUID5001
77451-301-10Hand Sanitizer500 mL in 1 BOTTLELIQUID5001
77451-301-11Hand Sanitizer1000 mL in 1 BOTTLELIQUID10001
77451-301-12Hand Sanitizer1000 mL in 1 BOTTLELIQUID10001
77451-301-13Hand Sanitizer1200 mL in 1 BOTTLELIQUID12001
77451-301-14Hand Sanitizer1200 mL in 1 BOTTLELIQUID12001
77451-301-15Hand Sanitizer4000 mL in 1 BOTTLELIQUID40001
77451-301-16Hand Sanitizer4000 mL in 1 BOTTLELIQUID40001
77451-301-17Hand Sanitizer5000 mL in 1 BOTTLELIQUID50001
77451-301-18Hand Sanitizer5000 mL in 1 BOTTLELIQUID50001
77451-301-19Hand Sanitizer25000 mL in 1 BOTTLELIQUID250001
77451-301-20Hand Sanitizer25000 mL in 1 BOTTLELIQUID250001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77451-301HAND SANITIZER (ALCOHOL) LIQUID [JEWELLERY TIME LIMITED]1Legacy NDC, 20 package rows20200721_aae17b23-1ca2-2cf1-e053-2a95a90aaebc.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
77451-30177451-301-01, 77451-301-02, 77451-301-03, 77451-301-04, 77451-301-05, 77451-301-06, 77451-301-07, 77451-301-08, 77451-301-09, 77451-301-10, 77451-301-11, 77451-301-12, 77451-301-13, 77451-301-14, 77451-301-15, 77451-301-16, 77451-301-17, 77451-301-18, 77451-301-19, 77451-301-20

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
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
aae17b23-1c94-2cf1-e053-2a95a90aaebcaae17b23-1ca2-2cf1-e053-2a95a90aaebc2020-07-20WarningsExact identifier
spl id: aae17b23-1c94-2cf1-e053-2a95a90aaebc
spl set id: aae17b23-1ca2-2cf1-e053-2a95a90aaebc

Reported adverse events (FAERS/openFDA)#

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