Label: HAND SANITIZING WITH LAVENDER OIL- alcohol gel

  • NDC Code(s): 59088-413-06, 59088-413-08, 59088-413-14, 59088-413-31, view more
    59088-413-36, 59088-413-39
  • Packager: PureTek Corporation
  • 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 June 5, 2020

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  • Active Ingredient

    Alcohol 62% (v/v)

  • Purpose

    Anti-Bacterial

  • Uses

    ■ Hand sanitizer to help reduce bacteria on the skin

  • Warnings

    ■ Flammable. Keep away from fire or flame.

  • When using this product

    ■ do not use in or near eyes. In case of contact, rinse eyes throughly with water

  • Stop use and ask a doctor if

    ■ irritation or redness develop and last for more than 72 hours

  • Keep out of reach of children

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

  • Directions

    ■ Dispense and rub onto hands until dry. Do not rinse off.

    ■ Children under 6 years of age should use this product under supervision.

    ■ repeat as necessary

  • Other information

    ■ Do not store above 110°F (43°C)

  • Inactive ingredients

    Aloe Barbadensis (aloe vera) Leaf Juice, Butyrospermum Parkii (Shea) Butter, Glycerin, Lavandula Angustifolia (Lavender) Oil, Panthenol, Polyacrylate Crosspolymer-6, Water (Aqua)

  • GenRx Hand Sanitizing Gel with Lavender

    Manufactured in the USA by PureTek Corporation
    Panorama City, CA 91402 USA
    877-921-7873
    www.genrxwoundcare.com

    List No:41431JLA

    NDC 59088-413-08

    4 floz Label

    NDC 59088-413-31

    16.9 floz

    NDC 59088-413-39

    24 FLOZ

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZING WITH LAVENDER OIL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-413
    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
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WATER (UNII: 059QF0KO0R)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-413-061 in 1 KIT06/05/2020
    1NDC:59088-413-39710 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59088-413-361 in 1 KIT06/05/2020
    2NDC:59088-413-141 in 1 KIT
    2NDC:59088-413-08118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59088-413-31500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/05/2020
    Labeler - PureTek Corporation (785961046)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTek Corporation785961046manufacture(59088-413) , label(59088-413)
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