FDA.reportPublic FDA data

Dermo Real

Manufacturer
Saflosa Industria Real, S.A. de C.V.
Effective date
2020-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:14

Label at a glance#

ProductDermo Real
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

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

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

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

  •  In children less than 2 months of age
  •  on open skin wounds.

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.

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

  • Store between 15-30ºC (59-86ºF)
  • Avoid freezing and excessive heat above 40ºC (104ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, fragrance, glycerin, triethanolamine, water.

SPL UNCLASSIFIED SECTION

Kills 99.9% of Most Illness Causing Germs

with Glycerin

@Real Skin Care Mx

Manufactured by:

SAFLOSA INDUSTRIA REAL, S.A. DE C.V.
Calle Poza Rica No. 9 Col. Arbol Grande C.P. 33739
Cd. Camargo, Chihuahua, México.

Tels.: (648) 462-1417
www.saflosa.com         

www.realskincare.com.mx

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

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
78009-110-012022-01-28C16284748780-1d6a99b39-58cc-a426-e053-dadaa90af4c2Dermo Real ® SKIN CARE Moisturising Hand Sanitizer
78009-110-022022-01-28C16284748780-1d6a99b39-58cc-a426-e053-dadaa90af4c2Dermo Real ® SKIN CARE Moisturising Hand Sanitizer
78009-110-032022-01-28C16284748780-1d6a99b39-58cc-a426-e053-dadaa90af4c2Dermo Real ® SKIN CARE Moisturising Hand Sanitizer
78009-110-062022-01-28C16284748780-1d6a99b39-58cc-a426-e053-dadaa90af4c2Dermo Real ® SKIN CARE Moisturising Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78009-110-01Dermo Real3785 mL in 1 BOTTLEGEL37851
78009-110-02Dermo Real960 mL in 1 BOTTLE, PUMPGEL9601
78009-110-03Dermo Real960 mL in 1 BOTTLEGEL9601
78009-110-06Dermo Real30 mL in 1 BOTTLEGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78009-110DERMO REAL (ETHYL ALCOHOL) GEL [SAFLOSA INDUSTRIA REAL, S.A. DE C.V.]1Legacy NDC, 4 package rows20200529_dc09c55b-3c64-45c3-9e51-34b0b76e8563.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
78009-11078009-110-06, 78009-110-02, 78009-110-03, 78009-110-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
e465a1ce-44d8-4e92-a36c-7688cc3ffc7ddc09c55b-3c64-45c3-9e51-34b0b76e85632020-05-20WarningsExact identifier
spl id: e465a1ce-44d8-4e92-a36c-7688cc3ffc7d
spl set id: dc09c55b-3c64-45c3-9e51-34b0b76e8563

Reported adverse events (FAERS/openFDA)#

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