Label: CLEANZE HAND SANITIZING- 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 December 11, 2020

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  • Active Ingredient

    Ethyl Alcohol 71%

    Purpose

    Antiseptic

  • USE

    For hand sanitizing to decrease bacteria on the skin
    Recommended for repeated use.

  • Warning

    For external use only. Flammable. Keep away from fire or flame. When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
    Discontinue use if irritation and redness develop. lf condition persists for more than 72 hours consult a physician.

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

  • Directions

    Directions . Pump a small amount in your palm and briskly rub hands together until dry.
    Children under 6 years of age should be supervised when in use. Other information . Store between 15 and 30C(59 and 86F).· Avoid freezing and excessive heat above 40C(104F).

  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, Carbomer,Glycerin,Tocopheryl Acetate (Vitamin E), Triethanolamine, Water(Aqua).

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    CLEANZE HAND SANITIZING 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77720-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL71 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77720-014-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/10/2020
    2NDC:77720-014-08414 mL in 1 BOTTLE; Type 0: Not a Combination Product12/10/2020
    3NDC:77720-014-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product12/10/2020
    4NDC:77720-014-0329 mL in 1 BOTTLE; Type 0: Not a Combination Product12/10/2020
    5NDC:77720-014-05100 mL in 1 BOTTLE; Type 0: Not a Combination Product12/10/2020
    6NDC:77720-014-06237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/10/2020
    7NDC:77720-014-0755 mL in 1 BOTTLE; Type 0: Not a Combination Product12/10/2020
    8NDC:77720-014-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/10/2020
    9NDC:77720-014-09946 mL in 1 BOTTLE; Type 0: Not a Combination Product12/10/2020
    10NDC:77720-014-103780 mL in 1 BOTTLE; Type 0: Not a Combination Product12/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/10/2020
    Labeler - Skaffles Group Limited Liability Company (831115642)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD544493972manufacture(77720-014)
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