Label: HAND SANITIZER GRAPEFRUIT GROVE- 62% 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 January 25, 2021

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  • Active ingredient

    Ethyl Alcohol 62%

    Purpose

    Antiseptic

  • Uses

    Helps reduce bacteria on the skin

    Recommended for repeated use

  • Warnings

    For external use only

    Flammable, keep away from fire, sparks, and sources if ignition. Do not store above 104 oF/40 oC

    When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin

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

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

  • Directions

    Dispense directly on hands and rub in thoroughly

    For children under 6, use adult supervision

    Not recommended for infants

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citral, Citric Acid, Citrus Paradisi (Grapefruit) Peel Oil, Ethyl Butyrate, Gamma-Undecalactone, Glycerin, Grapefruit Mercaptan, Hydroxypropyl Guar, Limonene, Maltol, Methylbenzyl Acetate, Triethyl Citrate, Water

  • 8 oz label

    8 oz

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  GRAPEFRUIT GROVE
    62% ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69366-315
    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
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ETHYL BUTYRATE (UNII: UFD2LZ005D)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    CITRAL (UNII: T7EU0O9VPP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    1-P-MENTHENE-8-THIOL (UNII: 7AT54D0N8R)  
    GUARAPROLOSE (1300 MPA.S AT 1%) (UNII: 1530WMS90S)  
    MALTOL (UNII: 3A9RD92BS4)  
    .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)  
    METHYLBENZYL ACETATE (UNII: P4RVP859F5)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69366-315-05236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/31/2017
    Labeler - The Honest Company (969962757)
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