Label: DERMO REAL- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 20, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

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

  • Warnings

    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.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • 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

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

    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

    untitled

  • INGREDIENTS AND APPEARANCE
    DERMO REAL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78009-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78009-110-0630 mL in 1 BOTTLE; Type 0: Not a Combination Product05/24/2020
    2NDC:78009-110-02960 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/24/2020
    3NDC:78009-110-03960 mL in 1 BOTTLE; Type 0: Not a Combination Product05/24/2020
    4NDC:78009-110-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/24/2020
    Labeler - Saflosa Industria Real, S.A. de C.V. (821354313)
    Establishment
    NameAddressID/FEIBusiness Operations
    Saflosa Industria Real, S.A. de C.V.821354313manufacture(78009-110)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!