FDA.reportPublic FDA data

Devolver Premium Tissue

Manufacturer
Devolver Cosmetics Co., Ltd
Effective date
2020-07-30
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:23:14

Label at a glance#

ProductDevolver Premium Tissue
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

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

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

Uses

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, Hydroxy Acetophenone, Cetylpyridinium Chloride, Citric Acid, Butylene Glycol, Aloe ferox leaf extract, Fragrance (Lime)

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100g NDC: 75001-204-01 Label 1100g NDC: 75001-204-01 Label 1

100g NDC: 75001-204-01 Label 2100g NDC: 75001-204-01 Label 2

100g NDC: 75001-204-02 Label 1100g NDC: 75001-204-02 Label 1

100g NDC: 75001-204-02 Label 2100g NDC: 75001-204-02 Label 2

100g NDC: 75001-204-03 Label 1100g NDC: 75001-204-03 Label 1

100g NDC: 75001-204-03 Label 2100g NDC: 75001-204-03 Label 2

100g NDC: 75001-204-04 Label 1100g NDC: 75001-204-04 Label 1

100g NDC: 75001-204-04 Label 2100g NDC: 75001-204-04 Label 2

335g NDC: 75001-204-05 Label 1335g NDC: 75001-204-05 Label 1

335g NDC: 75001-204-05 Label 2335g NDC: 75001-204-05 Label 2

335g NDC: 75001-204-06 Label 1335g NDC: 75001-204-06 Label 1

335g NDC: 75001-204-06 Label 2335g NDC: 75001-204-06 Label 2

100g NDC: 75001-204-07 Label100g NDC: 75001-204-07 Label

300g NDC: 75001-204-08 Label300g NDC: 75001-204-08 Label

400g NDC: 75001-204-09 Label400g NDC: 75001-204-09 Label

500g NDC: 75001-204-10 Label500g NDC: 75001-204-10 Label

800g NDC: 75001-204-11 Label800g NDC: 75001-204-11 Label

1100g NDC: 75001-204-12 Label1100g NDC: 75001-204-12 Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75001-204-012022-01-28C16284748780-1d6a99b39-4473-a426-e053-dadaa90af4c275001-204
75001-204-022022-01-28C16284748780-1d6a99b39-4473-a426-e053-dadaa90af4c275001-204
75001-204-032022-01-28C16284748780-1d6a99b39-4473-a426-e053-dadaa90af4c275001-204
75001-204-042022-01-28C16284748780-1d6a99b39-4473-a426-e053-dadaa90af4c275001-204
75001-204-052022-01-28C16284748780-1d6a99b39-4473-a426-e053-dadaa90af4c275001-204
75001-204-062022-01-28C16284748780-1d6a99b39-4473-a426-e053-dadaa90af4c275001-204
75001-204-072022-01-28C16284748780-1d6a99b39-4473-a426-e053-dadaa90af4c275001-204
75001-204-082022-01-28C16284748780-1d6a99b39-4473-a426-e053-dadaa90af4c275001-204
75001-204-092022-01-28C16284748780-1d6a99b39-4473-a426-e053-dadaa90af4c275001-204
75001-204-102022-01-28C16284748780-1d6a99b39-4473-a426-e053-dadaa90af4c275001-204
75001-204-112022-01-28C16284748780-1d6a99b39-4473-a426-e053-dadaa90af4c275001-204
75001-204-122022-01-28C16284748780-1d6a99b39-4473-a426-e053-dadaa90af4c275001-204

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75001-204-01Devolver Premium Tissue100 g in 1 POUCHLIQUID1007
75001-204-02Devolver Premium Tissue100 g in 1 POUCHLIQUID1007
75001-204-03Devolver Premium Tissue100 g in 1 POUCHLIQUID1007
75001-204-04Devolver Premium Tissue100 g in 1 POUCHLIQUID1007
75001-204-05Devolver Premium Tissue335 g in 1 POUCHLIQUID3357
75001-204-06Devolver Premium Tissue335 g in 1 POUCHLIQUID3357
75001-204-07Devolver Premium Tissue100 g in 1 POUCHLIQUID1007
75001-204-08Devolver Premium Tissue300 g in 1 BOTTLELIQUID3007
75001-204-09Devolver Premium Tissue400 g in 1 BOTTLELIQUID4007
75001-204-10Devolver Premium Tissue500 g in 1 BOTTLELIQUID5007
75001-204-11Devolver Premium Tissue800 g in 1 BOTTLELIQUID8007
75001-204-12Devolver Premium Tissue1100 g in 1 BOTTLELIQUID11007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75001-204DEVOLVER PREMIUM TISSUE (ALCOHOL) LIQUID [DEVOLVER COSMETICS CO., LTD]7Legacy NDC, 12 package rows20200731_a5b78bff-3c8d-5067-e053-2a95a90aedb0.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
75001-20475001-204-01, 75001-204-02, 75001-204-03, 75001-204-04, 75001-204-05, 75001-204-06, 75001-204-07, 75001-204-08, 75001-204-09, 75001-204-10, 75001-204-11, 75001-204-12

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
ALOE FEROX LEAF0D145J8EMEIACT
ALCOHOL3K9958V90MACTIB
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
LIME (CALCIUM OXIDE)C7X2M0VVNHIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT

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
abb1fbe4-248f-9d75-e053-2995a90ad428a5b78bff-3c8d-5067-e053-2a95a90aedb02020-07-30WarningsExact identifier
spl id: abb1fbe4-248f-9d75-e053-2995a90ad428
spl set id: a5b78bff-3c8d-5067-e053-2a95a90aedb0

Reported adverse events (FAERS/openFDA)#

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