Label: ORCHARD DE FLORE INSTANT HAND SANITIZER- 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 June 11, 2020

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

View All Sections
  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 75%

    Purpose

    Antiseptic

  • Uses

    • For hand sanitizing to decrease bacteria on the skin

    • Recommended for repeated use

  • Warnings

    For external use only

    When using this product:

    avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if:

    irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children.

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

  • Directions

    Squeeze appropriate amount of sanitizer on to hands and rub together until dry. Use as needed. For children under 6, use with adult supervision. Not recommended for infants.

  • Inactive Ingredients

    Water, Aloe Barbadensis Leaf Extract, Acrylates/C10-30 alkyl Acrylate Crosspolymer, Tetrahydroxypropyl Ethylenediamine.

  • Package Labeling:250ml

    Label2

  • Package Labeling:500ml

    Label3

  • INGREDIENTS AND APPEARANCE
    ORCHARD DE FLORE INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78733-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETOL (UNII: Q4R969U9FR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78733-015-00250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/28/2020
    2NDC:78733-015-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/28/2020
    Labeler - SONORA CORPORATION (791913234)
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!