Label: ORCHID AND ME MOISTURIZING 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 October 27, 2020

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

  • Active Ingredient

    Alcohol 77% v/v.

  • Purpose

    Antiseptic

  • Use

    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 and on open skin wounds

  • WHEN USING

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800222-1222.

  • 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)

    Questions?

    1-800-571-8254 Mon-Fri 9:00 AM- 5:00 PM (EST)

  • Inactive ingredients

    Aqua, Avena sativa Kernel Oil, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Medica Limonum (Lemon) Peel Oil, Galactoarabinan, Glycerin, Honey, Sodium Hyaluronate, Triethanolamine

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    ORCHID AND ME MOISTURIZING HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90018-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL77 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HONEY (UNII: Y9H1V576FH)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    LEMON OIL (UNII: I9GRO824LL)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90018-002-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    2NDC:90018-002-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    3NDC:90018-002-03250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
    4NDC:90018-002-04500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
    5NDC:90018-002-051000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
    6NDC:90018-002-06300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
    7NDC:90018-002-07310 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
    8NDC:90018-002-08330 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2020
    Labeler - ORCHID & ME ORGANICS & PRODUCTS COMPANY LIMITED (662953398)