FDA.reportPublic FDA data

Hawyy Hand Sanitizer

Manufacturer
TBC PERFUMES E COSMETICOS LTDA
Effective date
2020-12-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:34:43

Label at a glance#

ProductHawyy Hand Sanitizer
Active ingredientALCOHOL
Label structure8 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 15-30 °C (59-86 °F) Avoid freezing and excessive heat above 40 °C (104 °F)

Label contents#

Full prescribing information#

Drug Facts Panel - Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Denatured Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Drug Facts Panel - Purpose

OTC - PURPOSE SECTION

Purpose: Antiseptic.

Drug Facts Panel - Use

INDICATIONS & USAGE SECTION

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

Drug Facts Panel - Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.
Do not use
● in children less than 2 months of age
● on open skin wounds
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 - DO NOT USE SECTION

Do not use
● 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.

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.

Drug Facts Panel - 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.

Drug Facts Panel - Other Information

STORAGE AND HANDLING SECTION

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

Drug Facts Panel - Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Carbomer, Fragrance, Propylene Glycol, Triethanolamine, Water.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

120 ml, NDC 78906-001-01

Label 120 mlLabel 120 ml

200 ml, NDC 78906-001-02

Label 200 mlLabel 200 ml

500 ml, bottle NDC 78906-001-03

500 ml, pump NDC 78906-001-04

Label 500 mlLabel 500 ml

5000 ml NDC 78906-001-05

Label 5000 mlLabel 5000 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78906-001-012022-01-28C16284748780-1d6a99b39-9958-a426-e053-dadaa90af4c2NO CHANGE NOTIFICATION
78906-001-022022-01-28C16284748780-1d6a99b39-9958-a426-e053-dadaa90af4c2NO CHANGE NOTIFICATION
78906-001-032022-01-28C16284748780-1d6a99b39-9958-a426-e053-dadaa90af4c2NO CHANGE NOTIFICATION
78906-001-042022-01-28C16284748780-1d6a99b39-9958-a426-e053-dadaa90af4c2NO CHANGE NOTIFICATION
78906-001-052022-01-28C16284748780-1d6a99b39-9958-a426-e053-dadaa90af4c2NO CHANGE NOTIFICATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78906-001-01Hawyy Hand Sanitizer120 mL in 1 BOTTLEGEL1203
78906-001-02Hawyy Hand Sanitizer200 mL in 1 BOTTLEGEL2003
78906-001-03Hawyy Hand Sanitizer500 mL in 1 BOTTLEGEL5003
78906-001-04Hawyy Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5003
78906-001-05Hawyy Hand Sanitizer5000 mL in 1 JUGGEL50003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78906-001HAWYY HAND SANITIZER (ETHYL ALCOHOL) GEL [TBC PERFUMES E COSMETICOS LTDA]3Legacy NDC, 5 package rows20201208_aa66371e-b000-1acd-e053-2995a90a788a.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
78906-00178906-001-01, 78906-001-02, 78906-001-03, 78906-001-04, 78906-001-05

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
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT

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
b5e164bf-84b2-2c21-e053-2a95a90a315baa66371e-b000-1acd-e053-2995a90a788a2020-12-07WarningsExact identifier
spl id: b5e164bf-84b2-2c21-e053-2a95a90a315b
spl set id: aa66371e-b000-1acd-e053-2995a90a788a

Reported adverse events (FAERS/openFDA)#

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