Label: PREFACE EARTH BABY HAND SANITIZER GEL- organic ethyl 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 March 22, 2021

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 62% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • WARNINGS

    For external use only. Flammable. Keep away from fire or flame.

  • WHEN USING

    When using this product avoid contact with eyes. If eye contact occurs, rinse with water.

  • STOP USE

    Stop use and ask a doctor if skin irritation or redness develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Uses to help reduce bacteria on the skin

  • DOSAGE & ADMINISTRATION

    Directions apply enough gel to wet hands and rub together until dry. Use 1 to 3 times daily.

  • STORAGE AND HANDLING

    Other information do not store above 104°F (40°C).

  • INACTIVE INGREDIENT

    Inactive ingredients Aloe Barbadensis Leaf Juice*, Carthamus Tinctorius (Safflower) Oleosomes*, Glycerin, Hydroxyethylcellulose, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Alcohol, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Parfum (Fragrance Natural), Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Hyaluronate.

    *Certified Organic Ingredient

  • PRINCIPAL DISPLAY PANEL

    EBPHSG2PEBHSG2DF

  • INGREDIENTS AND APPEARANCE
    PREFACE EARTH BABY HAND SANITIZER GEL 
    organic ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62588-910
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ROSEMARY (UNII: IJ67X351P9)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62588-910-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/202002/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/01/202002/01/2024
    Labeler - Earth Baby, Inc (079298651)
    Registrant - V Manufacturing & Logistics, Inc. (079081508)