Label: TERRA PURE SPA COLLECTION FRESH ALOE 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 August 3, 2020

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  • Drug Facts

  • Active ingredient

    Ethanol (Alcohol)75% v/v

    Purpose

    Antiseptic

  • Use

    hand sanitizer to help reduce bacteria on the skin

  • Warnings

    for external use only:hands

    Do not use

    in children less than 2 months of age.

    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 redness occurs.

    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.
    • For children under 6, use only under adult supervision.
  • Other information

    • Store between 15-30°C (59-86°F)
    • Avoid freezing and excessive heat above 40°C (104°F)
  • Inactive ingredients

    Water, Dichlorobenzyl alcohol, Acrylates/C10-30 alkyl acrylate crosspolymer, Triethanolamine, Methyl Gluceth-20, Glycerin, Aloe Barbadensis Leaf Juice, Tocopherol, Fragrance, FD&C Yellow NO.5, FD&C Blue No.1

  • Package Labeling

    Bottle

  • INGREDIENTS AND APPEARANCE
    TERRA PURE SPA COLLECTION FRESH ALOE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77849-004
    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)  
    DICHLOROBENZYL ALCOHOL (UNII: 1NKX3648J9)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77849-004-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/15/2020
    Labeler - Yangzhou Eco-Amenities CO., Ltd (543786608)
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