Label: LULULEMON SELFCARE NO NASTIES HAND SANITIZER- alcohol solution

  • NDC Code(s): 52261-8700-1, 52261-8700-2
  • Packager: Cosco International, Inc.
  • 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 April 29, 2021

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  • ACTIVE INGREDIENT:

    Ethyl Alcohol 70% v/v.................Purpose: Antiseptic

  • PURPOSE:

    Antiseptic

  • USES:

    • Hand Sanitizer to decrease bacteria on the skin
    • For use when soap and water are not available
    • Recommended for repeated use
  • WARNINGS:

    • For external use only
    • Flammable! Keep away from heat or flame
  • CAUTIONS:

    • Do not use in children less than 2 months of age or on open skin wounds
  • WHEN USING

    • When using this product keep out of eyes, ears, and mouth. If contact occurs, rinse thoroughly with water.
  • STOP USE

    • Stop use and ask a doctor if rash or irratation develops and last more than 24 hours.
  • KEEP OUT OF REACH OF CHILDREN

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

    • Rub thoroughly into hands and allow to dry
    • Children under 6 years of age should be supervised when using this product
  • INACTIVE INGREDIENTS:

    Ammonium Acryloyldimethyltaurate, Bergamot Oil, Brazilian Pepper, Bitter Orange Oil,
    Carboxymethylcellulose Sodium, Carrageenan, Cetyl Lactate, Chitosan Oligosaccharide, Citric Acid
    Monohydrate, Citrus Aurantium Flower, Citrus Aurantium Fruit Rind, Cyberlindnera Jadinii, Dipropylene
    Glycol, Geranium Flower Oil, Ginger Oil, Glycerin, Isoeicosane, Juniperus Virginiana Oil, Lactococcus
    Lactis, Lauryl Lactate, Lemon Oil, Lemon Peel, Leuconostoc/Radish Root Ferment Filtrate, Myristyl
    Lactate, Orange Oil, Potassium Sorbate, Propanediol, Rosemary Oil, Saccharomyces Cerevisiae, Santalum
    Album Seed Oil, Sodium Alginate, Sodium Benzoate, Sorbitan Monooleate, Xanthan Gum, Water, Yeast

  • OTHER INFORMATION:

    • Store at room temperature 68° F to 77° F (20° to 25° C)
    • Do not expose to heat or open flame
    • May discolor certain fabrics 
  • FOR QUESTIONS:

    Call 1-877-263-9300

  • PRINCIPAL DISPLAY PANEL

    50ml CAN

    50ml USA

  • PRINCIPAL DISPLAY PANEL

    500ml CAN

    500ml USA

  • INGREDIENTS AND APPEARANCE
    LULULEMON SELFCARE NO NASTIES HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-8700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    BRAZILIAN PEPPER (UNII: SUG822G7CD)  
    BITTER ORANGE OIL (UNII: 9TLV70SV6I)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    CETYL LACTATE (UNII: A7EVH2RK4O)  
    CHITOSAN OLIGOSACCHARIDE (UNII: 23R93M6Y64)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)  
    CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOEICOSANE (UNII: AR294KAG3T)  
    JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
    LACTOCOCCUS LACTIS (UNII: F1A0PSN10V)  
    LAURYL ACETATE (UNII: 76J36KE44B)  
    LEMON OIL (UNII: I9GRO824LL)  
    LEMON PEEL (UNII: 72O054U628)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    MYRISTYL LACTATE (UNII: 1D822OC34X)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    CYBERLINDNERA JADINII (UNII: 8JRL032K80)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    SANTALUM ALBUM SEED OIL (UNII: J8A90C3A98)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    YEAST (UNII: 3NY3SM6B8U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-8700-10.05 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
    2NDC:52261-8700-20.500 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/01/2021
    Labeler - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-8700)
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