Label: 100% PURE HAND SANITIZER HYDRATING- 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 August 3, 2020

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  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    For cleaning hands when water is not available to help reduce bacteria on the skin. Recommended for repeated use.

  • Warnings:

    • ​For external use only.
  • STORAGE AND HANDLING

    • Flammable, keep away from fire, sparks, and sources of ignition.
    • Do not store above 104°F/40°C.
  • WHEN USING

    • When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • KEEP OUT OF REACH OF CHILDREN

    • ​ Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center immediately.
  • OTHER SAFETY INFORMATION

    • Avoid contact with broken skin.
  • STOP USE

    • Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
  • Directions:

    Dispense directly on hands and rub in thoroughly. For children under 6, use adult supervision. Not recommended for infants.

  • Other Ingredients:

    Aloe Barbadensis (Aloe Vera) Leaf Juice*, Glycerin, Hydroxypropyl Guar, Citric Acid, Aqua (Water) *Organic Ingredient

  • Questions or Comments?

    Call 1.415.814.9788 or visit www.100PercentPure.com

  • PRINCIPAL DISPLAY PANEL

    100% Pure Hand Sanitizer Hydrating Gel

    Product NDC 52667-011 Label

  • INGREDIENTS AND APPEARANCE
    100% PURE HAND SANITIZER  HYDRATING
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52667-011
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GUARAPROLOSE (1300 MPA.S AT 1%) (UNII: 1530WMS90S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52667-011-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    2NDC:52667-011-02473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/03/2020
    Labeler - Purity Cosmetics (055795259)
    Registrant - Our Babylon LLC (105266218)
    Establishment
    NameAddressID/FEIBusiness Operations
    Our Babylon LLC105266218manufacture(52667-011)
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