Devolver Premium-Spray

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-Spray
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 75%

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

Water, Glycerin, Butylene Glyol, Aloe Barbadensis Leaf Powder, Fragrance

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100ml NDC: 75001-202-01 Label100ml NDC: 75001-202-01 Label

236ml NDC: 75001-202-02 Label236ml NDC: 75001-202-02 Label

500ml NDC: 75001-202-03 Label500ml NDC: 75001-202-03 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047755ethanol 75 % Topical SolutionPSN2
1047755ethanol 0.75 ML/ML Topical SolutionSCD2
1047755ethanol 75 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75001-202-012022-01-28C16284748780-1d6a99b39-3fa8-a426-e053-dadaa90af4c275001-202
75001-202-022022-01-28C16284748780-1d6a99b39-3fa8-a426-e053-dadaa90af4c275001-202
75001-202-032022-01-28C16284748780-1d6a99b39-3fa8-a426-e053-dadaa90af4c275001-202

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75001-202-01Devolver Premium-Spray100 mL in 1 BOTTLE, SPRAYLIQUID1002
75001-202-02Devolver Premium-Spray236 mL in 1 BOTTLE, SPRAYLIQUID2362
75001-202-03Devolver Premium-Spray500 mL in 1 BOTTLE, SPRAYLIQUID5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75001-202DEVOLVER PREMIUM-SPRAY (ALCOHOL) LIQUID [DEVOLVER COSMETICS CO., LTD]2Legacy NDC, 3 package rows20200603_a4aa977e-80de-3ba3-e053-2995a90a2ad7.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75001-20275001-202-01, 75001-202-02, 75001-202-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
a7194e67-7d05-14b6-e053-2a95a90ac021a4aa977e-80de-3ba3-e053-2995a90a2ad72020-06-02WarningsExact identifier
spl id: a7194e67-7d05-14b6-e053-2a95a90ac021
spl set id: a4aa977e-80de-3ba3-e053-2995a90a2ad7

Reported adverse events (FAERS/openFDA)#

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