FDA.reportPublic FDA data

Delma

Manufacturer
Delma Global, Inc | Ningbo Pasco United Industry Co., Ltd.
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:00

Label at a glance#

ProductDelma
Active ingredientALCOHOL
Label structure12 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

Avoid freezing and excessive heat above the 40C (104 F) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

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

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.
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 - 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.

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.

Other information

STORAGE AND HANDLING SECTION

Avoid freezing and excessive heat above the 40C (104 F)

May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis extract, aminomethyl propanol, carbomer, caprylyl glycol, glycerin, isopropyl alcohol, isopropyl myristate, propylene glycol, tocopheryl acetate, water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 mL NDC: 80208-112-03236 mL NDC: 80208-112-03

236 mL NDC: 80208-112-03

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
80208-112-012023-07-28C16284748780-10191ceaa-6e38-198a-e063-dbdaa90aec3eDelma Hand Sanitizer with Fragrance
80208-112-022023-07-28C16284748780-10191ceaa-6e38-198a-e063-dbdaa90aec3eDelma Hand Sanitizer with Fragrance
80208-112-032023-07-28C16284748780-10191ceaa-6e38-198a-e063-dbdaa90aec3eDelma Hand Sanitizer with Fragrance
80208-112-042023-07-28C16284748780-10191ceaa-6e38-198a-e063-dbdaa90aec3eDelma Hand Sanitizer with Fragrance

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80208-112-01Delma30 mL in 1 BOTTLEGEL303
80208-112-02Delma59 mL in 1 BOTTLEGEL593
80208-112-03Delma236 mL in 1 BOTTLEGEL2363
80208-112-04Delma591 mL in 1 BOTTLEGEL5913

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80208-112DELMA (HAND SANITIZER) GEL [DELMA GLOBAL, INC]3Legacy NDC, 4 package rows20220115_addbf0fb-c2a7-0c47-e053-2a95a90a98d8.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80208-11280208-112-01, 80208-112-02, 80208-112-03, 80208-112-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FRAGRANCE LEMON ORC2001060K1725A7G95IACT

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
d58e2af9-9d21-bf44-e053-2a95a90aec59addbf0fb-c2a7-0c47-e053-2a95a90a98d82022-01-14WarningsExact identifier
spl id: d58e2af9-9d21-bf44-e053-2a95a90aec59
spl set id: addbf0fb-c2a7-0c47-e053-2a95a90a98d8

Reported adverse events (FAERS/openFDA)#

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