Label: SKININC- 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 October 7, 2020

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

View All Sections
  • Active Ingredients

    Denatured Ethyl Alcohol 65% v/v

  • Purpose

    Antimicrobial.

  • Warnings

    • Flammable. Keep away from fire or flame.
    • For external use only.
    • When using this product do not use it in or near eyes. In case of contact, rinse eyes thoroughly with water.
    • Stop use and ask a doctor if irritation or rash appears and lasts.
    • Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
  • Uses

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

    • Place enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using this product.
  • KEEP OUT OF REACH OF CHILDREN

  • Other Information 

    • Store below 1100F(430C)
    • May discolour certain fabrics.
  • Inactive Ingredient

    Water,Mannitol,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Aminomethyl Propanol,Microcrystalline Cellulose,PEG-20 Sorbitan Cocoate,Carbomer,Disodium EDTA,Butylene Glycol,1,2-Hexanediol,Mentha Rotundifolia Leaf Extract,Mentha Piperita (Peppermint) Leaf Extract,Mentha Aquatica Leaf Extract,Cucurbita Pepo (Pumpkin) Fruit Extract,Perilla Frutescens Extract,Rheum Palmatum Root Extract,Angelica Gigas Extract,Cnidium Officinale Root Extract,Melaleuca Alternifolia (Tea Tree) Leaf Extract, Fragrance

  • Product Image

    image description

  • INGREDIENTS AND APPEARANCE
    SKININC 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80761-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MANNITOL (UNII: 3OWL53L36A)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    MENTHA X ROTUNDIFOLIA LEAF (UNII: K59TXG2L3U)  
    MENTHA X PIPERITA WHOLE (UNII: 79M2M2UDA9)  
    MENTHA AQUATICA LEAF (UNII: 5M106ME6PT)  
    PUMPKIN (UNII: SYW0QUB89Y)  
    RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
    ANGELICA GIGAS ROOT (UNII: 32766B2FHX)  
    CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80761-001-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product10/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/07/2020
    Labeler - Skininc Global Pte. Ltd. (595292498)
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!