Label: DERMONANO- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 12, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Use

    Hand rub to help reduce bacteria that potentially can cause disease when water is 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 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Aqua, Carbomer, Isopropyl Alcohol, Aminomethyl Propanol, Panthenol, Triisopropanolamine

  • Questions or Comments

    PGH Laboratorios do Brasil Ltda.

    SAC (931) 444-6323

    sac@dermonano.com.br

  • Principal Display Panel

    NDC: 75751-070-04

    Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM

    Gel 70% (alcohol)

    Sanitation Effective against bacteria and germs

    Requires no water

    Danger: Flammable

    Keep out of reach of children

    Keep away from fire or flame

    For external use only

    See other cautions on opposite panel of label

    Net Wt. 120g e 4.2 oz

    Label

    NDC: 75751-070-16

    Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM

    Gel 70% (alcohol)

    Sanitation Effective against bacteria and germs

    Requires no water

    Danger: Flammable

    Keep out of reach of children

    Keep away from fire or flame

    For external use only

    See other cautions on opposite panel of label

    Gel 70% (alcohol)

    Net Wt. 480g e 16.9 oz

    Label 1

    NDC: 75751-070-26

    Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM

    Gel 70% (alcohol)

    Sanitation Effective against bacteria and germs

    Requires no water

    Danger: Flammable

    Keep out of reach of children

    Keep away from fire or flame

    For external use only

    See other cautions on opposite panel of label

    Gel 70% (alcohol)

    Net Wt. 1000L e 33814oz

    Label 2

  • INGREDIENTS AND APPEARANCE
    DERMONANO 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75751-070
    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
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75751-070-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
    2NDC:75751-070-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
    3NDC:75751-070-261000000 mL in 1 PACKAGE; Type 0: Not a Combination Product05/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/11/2020
    Labeler - PGH LABORATORIOS DO BRASIL LTDA. (903309948)
    Registrant - PGH LABORATORIOS DO BRASIL LTDA. (903309948)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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