FDA.reportPublic FDA data

Hand Sanitizer Gel

Manufacturer
TAMSC INC. | Zhejiang Enchant Cosmetic Co., Ltd.
Effective date
2020-08-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:26

Label at a glance#

ProductHand Sanitizer Gel
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product. Not recommended for infants.

Storage and handling

Do not store above 105oF (40oC). May discolor certain fabrics. Harmful to wood finishes and plastics.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antimicrobial, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin.
Recommended for repeated use.

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

  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.
  • Not recommended for infants.

Other information

STORAGE AND HANDLING SECTION

  • Do not store above 105oF (40oC).
  • May discolor certain fabrics.
  • Harmful to wood finishes and plastics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Carbomer, Aminomethyl Propanol, Aloe Barbadensis (Aloe Vera) Leaf Juice, Sodium Hyaluronate.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand Sanitizer GelHand Sanitizer Gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79485-100-102022-01-28C16284748780-1d6a99b39-ae49-a426-e053-dadaa90af4c2aa713d61-ae3e-6b8c-e053-2a95a90a9cd0
79485-100-202022-01-28C16284748780-1d6a99b39-ae49-a426-e053-dadaa90af4c2aa713d61-ae3e-6b8c-e053-2a95a90a9cd0
79485-100-302022-01-28C16284748780-1d6a99b39-ae49-a426-e053-dadaa90af4c2aa713d61-ae3e-6b8c-e053-2a95a90a9cd0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79485-100-10Hand Sanitizer Gel237 mL in 1 BOTTLE, PUMPGEL2372
79485-100-20Hand Sanitizer Gel100 mL in 1 BOTTLE, WITH APPLICATORGEL1002
79485-100-30Hand Sanitizer Gel50 mL in 1 BOTTLE, WITH APPLICATORGEL502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79485-100HAND SANITIZER GEL (ALCOHOL) GEL [TAMSC INC.]2Legacy NDC, 3 package rows20200812_aa713d61-ae3e-6b8c-e053-2a95a90a9cd0.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79485-10079485-100-20, 79485-100-10, 79485-100-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
HYALURONATE SODIUMYSE9PPT4THIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
ac9e6092-746d-5301-e053-2a95a90a1fd9aa713d61-ae3e-6b8c-e053-2a95a90a9cd02020-08-11WarningsExact identifier
spl id: ac9e6092-746d-5301-e053-2a95a90a1fd9
spl set id: aa713d61-ae3e-6b8c-e053-2a95a90a9cd0

Reported adverse events (FAERS/openFDA)#

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