MNFR SAFE

Manufacturer
SOMBRA COSMETICS
Effective date
2020-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:44

Label at a glance#

ProductMNFR SAFE
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Helps reduce bacteria on the skin that could cause diseases.

Dosage and administration

Place enough product in the palm of your hands to thoroughly cover your hands. Rub hands together briskly until product is completely absorbed and hands are dry.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (105F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

Helps reduce bacteria on the skin that could cause diseases.

Warnings

WARNINGS SECTION

Flammable. Keep fire or flame. For external use only.

Do not use

OTC - DO NOT USE SECTION

When using this product, do not use in or near the eyes.  In case of contact, rinse eyes thoroughly with water.

OTC - WHEN USING SECTION

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

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 in the palm of your hands to thoroughly cover your hands. Rub hands together briskly until product is completely absorbed and hands are dry.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
    Avoid freezing and excessive heat above 40C (105F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, purified water, carbomer, aminomethyl propanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-1115-12024-01-30C16284748780-11030e365-5be1-111a-e063-dadaa90a10e2MNFR SAFE Advanced Hand Sanitizer
61577-1115-82024-01-30C16284748780-11030e365-5be1-111a-e063-dadaa90a10e2MNFR SAFE Advanced Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-1115-1MNFR SAFE3785 mL in 1 BOTTLE, PLASTICGEL37851
61577-1115-8MNFR SAFE236 mL in 1 BOTTLE, PLASTICGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-1115MNFR SAFE (ALCOHOL) GEL [SOMBRA COSMETICS]1Legacy NDC, 2 package rows20200624_5debf95f-b9a1-470e-a85f-da486a522f5d.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-111561577-1115-8, 61577-1115-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
1eee64c5-0394-41d9-9d7f-bc2a9da1e0c45debf95f-b9a1-470e-a85f-da486a522f5d2020-06-22WarningsExact identifier
spl id: 1eee64c5-0394-41d9-9d7f-bc2a9da1e0c4
spl set id: 5debf95f-b9a1-470e-a85f-da486a522f5d

Reported adverse events (FAERS/openFDA)#

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