FDA.reportPublic FDA data

Devolver Hand Sanitizer

Manufacturer
Devolver Cosmetics Co.,Ltd | Skin n Skin Co., Ltd.
Effective date
2020-06-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:16:59

Label at a glance#

ProductDevolver Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Uses Hand sanitizer to help reduce bacteria that potentially can cause disease.

Dosage and administration

Directions • Wet hands thoroughly with product and allow to dry without wiping - For children under 6, use only under adult supervision.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
ETHANOL 70%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients
Water, Glycerin, Carbomer, Trolamine, Aloe Extract, Parsley Extract, Orange Oil, Limonene

PURPOSE

OTC - PURPOSE SECTION

Purpose: ANTISEPTIC

WARNINGS

WARNINGS SECTION

Warnings

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

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.

Uses

INDICATIONS & USAGE SECTION

Uses
Hand sanitizer to help reduce bacteria that potentially can cause disease.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions
• Wet hands thoroughly with product and allow to dry without wiping - For children under 6, use only under adult supervision.

Other information

OTHER SAFETY INFORMATION

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

PACKAGE LABEL - Devolver Hand Sanitizer Gel 100mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of tubeImage of tube

PACKAGE LABEL - Devolver Hand Sanitizer Gel 236mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

PACKAGE LABEL - Devolver Hand Sanitizer Gel 500mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500ml NDC: 75001-010-04 Label500ml NDC: 75001-010-04 Label

500ml NDC: 75001-010-05 Label500ml NDC: 75001-010-05 Label

500ml NDC: 75001-010-06 Label500ml NDC: 75001-010-06 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75001-010-012022-01-28C16284748780-1d6a99b39-c1fe-a426-e053-dadaa90af4c275001-010
75001-010-022022-01-28C16284748780-1d6a99b39-c1fe-a426-e053-dadaa90af4c275001-010
75001-010-032022-01-28C16284748780-1d6a99b39-c1fe-a426-e053-dadaa90af4c275001-010
75001-010-042022-01-28C16284748780-1d6a99b39-c1fe-a426-e053-dadaa90af4c275001-010
75001-010-052022-01-28C16284748780-1d6a99b39-c1fe-a426-e053-dadaa90af4c275001-010
75001-010-062022-01-28C16284748780-1d6a99b39-c1fe-a426-e053-dadaa90af4c275001-010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75001-010-01Devolver Hand Sanitizer100 mL in 1 TUBEGEL1002
75001-010-02Devolver Hand Sanitizer236 mL in 1 BOTTLE, PUMPGEL2362
75001-010-03Devolver Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5002
75001-010-04Devolver Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5002
75001-010-05Devolver Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5002
75001-010-06Devolver Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75001-010DEVOLVER HAND SANITIZER (ALCOHOL) GEL [DEVOLVER COSMETICS CO.,LTD]2Legacy NDC, 6 package rows20200610_f2a055b5-b2ff-4840-af2a-5aed59f252cf.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75001-01075001-010-01, 75001-010-02, 75001-010-03, 75001-010-04, 75001-010-05, 75001-010-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
ALOEV5VD430YW9IACT
PARSLEY58FMD0Q0EVIACT
ORANGE OILAKN3KSD11BIACT
LIMONENE, (+)-GFD7C86Q1WIACT
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
a7a82f7a-8ce4-d578-e053-2995a90ae353f2a055b5-b2ff-4840-af2a-5aed59f252cf2020-06-09WarningsExact identifier
spl id: a7a82f7a-8ce4-d578-e053-2995a90ae353
spl set id: f2a055b5-b2ff-4840-af2a-5aed59f252cf

Reported adverse events (FAERS/openFDA)#

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