Label: AROMATHERAPY HAND SANITIZER LAVENDER AND CHAMOMILE- 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 17, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol 65% 

  • Purpose

     Antiseptic

  • Use

    Decrease bacteria on hands.

  • Warnings

    For external use only.

    Flammable.Keep product away from fire or flame.

    When using this product

    avoid contact with eyes; in case of contact, flush eyes with water.

    Stop use and ask a doctor if

    irritation or redness develops and persists.

    Keep out of reach of children.

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

  • Directions

    Wet hands thoroughly with product and allow to dry.

  • Inactive ingredients

    Water (Aqua), ACRYLATES/C10-30 ALKYL ACRYLATE CROSSCOPOLYMER, AMINOMETHYL PROPANOL, Fragrance (Parfum), Chamomilla Recutita (Matricaria) Flower Oil, Lavandula Angustifolia (Lavender) Oil, Argania Spinosa Kernel Oil, May Contain: D&C Red No. 33 (Cl17200), FD&C Red No.4 (Cl14700), FD&C Yellow No. 5 (Cl19140), FD&C Blue No. 1 (Cl 42090).

  • SPL UNCLASSIFIED SECTION

    Warning - Choking Hazard

    Small parts. Not for children under 3 years. 

    No Animal Testing

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    AROMATHERAPY HAND SANITIZER LAVENDER AND CHAMOMILE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-417
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    May containFD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56136-417-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product10/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/17/2020
    Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-417)
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