FDA.reportPublic FDA data

Devolver Premium Gel

Manufacturer
Devolver Cosmetics Co., Ltd
Effective date
2020-06-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:15:45

Label at a glance#

ProductDevolver Premium Gel
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

DOSAGE & ADMINISTRATION SECTION

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

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

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - ASK DOCTOR SECTION

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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

INDICATIONS & USAGE SECTION

Wet hands thoroughly with product and allow to dry without wiping.

For children under 6, use only under adult supervision.

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

Purified Water, Glycerin, Carbomer, Fragrance, Trolamine, Aleo Extract(09), Parsley Extract

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60ml NDC: 75001-201-01 Label60ml NDC: 75001-201-01 Label

100ml NDC: 75001-201-02 Label100ml NDC: 75001-201-02 Label

236ml NDC: 75001-201-03 Label236ml NDC: 75001-201-03 Label

500ml NDC: 75001-201-04 Label500ml NDC: 75001-201-04 Label

3785ml NDC: 75001-201-05 Label3785ml NDC: 75001-201-05 Label

120ml NDC: 75001-201-06 Label120ml NDC: 75001-201-06 Label

350ml NDC: 75001-201-07 Label350ml NDC: 75001-201-07 Label

300ml NDC: 75001-201-08 Label300ml NDC: 75001-201-08 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
75001-201-012022-01-28C16284748780-1d6a99b39-a887-a426-e053-dadaa90af4c2a4a675f8-5edb-6aa0-e053-2995a90a6280
75001-201-022022-01-28C16284748780-1d6a99b39-a887-a426-e053-dadaa90af4c2a4a675f8-5edb-6aa0-e053-2995a90a6280
75001-201-032022-01-28C16284748780-1d6a99b39-a887-a426-e053-dadaa90af4c2a4a675f8-5edb-6aa0-e053-2995a90a6280
75001-201-042022-01-28C16284748780-1d6a99b39-a887-a426-e053-dadaa90af4c2a4a675f8-5edb-6aa0-e053-2995a90a6280
75001-201-052022-01-28C16284748780-1d6a99b39-a887-a426-e053-dadaa90af4c2a4a675f8-5edb-6aa0-e053-2995a90a6280
75001-201-062022-01-28C16284748780-1d6a99b39-a887-a426-e053-dadaa90af4c2a4a675f8-5edb-6aa0-e053-2995a90a6280
75001-201-072022-01-28C16284748780-1d6a99b39-a887-a426-e053-dadaa90af4c2a4a675f8-5edb-6aa0-e053-2995a90a6280
75001-201-082022-01-28C16284748780-1d6a99b39-a887-a426-e053-dadaa90af4c2a4a675f8-5edb-6aa0-e053-2995a90a6280

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75001-201-01Devolver Premium Gel60 mL in 1 BOTTLEGEL602
75001-201-02Devolver Premium Gel100 mL in 1 BOTTLEGEL1002
75001-201-03Devolver Premium Gel236 mL in 1 BOTTLE, PUMPGEL2362
75001-201-04Devolver Premium Gel500 mL in 1 BOTTLE, PUMPGEL5002
75001-201-05Devolver Premium Gel3785 mL in 1 BOTTLEGEL37852
75001-201-06Devolver Premium Gel120 mL in 1 BOTTLEGEL1202
75001-201-07Devolver Premium Gel350 mL in 1 BOTTLEGEL3502
75001-201-08Devolver Premium Gel300 mL in 1 BOTTLEGEL3002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75001-201DEVOLVER PREMIUM GEL (ALCOHOL) GEL [DEVOLVER COSMETICS CO., LTD]2Legacy NDC, 8 package rows20200603_a4a675f8-5edb-6aa0-e053-2995a90a6280.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75001-20175001-201-01, 75001-201-02, 75001-201-03, 75001-201-04, 75001-201-05, 75001-201-06, 75001-201-07, 75001-201-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
PETROSELINUM CRISPUM1WZA4Y92EXIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
a718fcbb-20ed-4230-e053-2995a90a0961a4a675f8-5edb-6aa0-e053-2995a90a62802020-06-02WarningsExact identifier
spl id: a718fcbb-20ed-4230-e053-2995a90a0961
spl set id: a4a675f8-5edb-6aa0-e053-2995a90a6280

Reported adverse events (FAERS/openFDA)#

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