Label: ALOE VERA HAND SANITIZER W/FRAGRANCE- 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 July 13, 2021

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  • Purpose

    Hand sanitizer to help reduce bacteria on the skin

  • Use

    hand sanitizer to help reduce bacteria on the skin

  • Warnings

    Flammable. Keep away from heat or flame.

    For external use only.

  • WHEN USING

    When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts..

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

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • 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.

  • Directions

    • Put enought product in your palm to cover all surfaces of both hands and rub hands together briskly until dry.
    • children under 6 years of age should be supervised when using this product.
  • Other information

    • Store below 110F
  • Inactive ingredients

    Aloe Vera Leaf Juice (Organic), Ammonium Polyacryloyl Dimethyl Taurate, Caprylyl Glycol, Fragrance, Glycerin, Isopropyl Myristate, Tocopheryl Acetate (Vitamin E), Water (Aqua)

  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

  • Package Label - Principal Display Panel

    Principal Display Panel 2oz

    8oz

    16oz

    128 oz

  • INGREDIENTS AND APPEARANCE
    ALOE VERA HAND SANITIZER W/FRAGRANCE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79949-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL34.6231 g  in 51.3338 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.37263 g  in 51.3338 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 8.87207 g  in 51.3338 g
    WATER (UNII: 059QF0KO0R) 6.38414 g  in 51.3338 g
    CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.2703 g  in 51.3338 g
    AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371) 0.64167 g  in 51.3338 g
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.12053 g  in 51.3338 g
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.02819 g  in 51.3338 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79949-001-0151.3338 g in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    2NDC:79949-001-033285.363 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/25/2020
    3NDC:79949-001-02205.3352 g in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    4NDC:79949-001-04410.6704 g in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/25/2020
    Labeler - L.O.D.C. Group, Ltd. (034768961)
    Registrant - Lily of the Desert (604850123)
    Establishment
    NameAddressID/FEIBusiness Operations
    L.O.D.C. Group, Ltd.034768961manufacture(79949-001)
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