Label: FRESH HAND ANTISEPTIC CLEANER- 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 1, 2022

If you are a consumer or patient please visit this version.

  • DRUG FACTS

  • ACTIVE INGREDIENT

    Ethyl Alcohol 60%

  • PURPOSE

    Antiseptic

  • USES

    Hand sanitizer to help reduce bacteria that potentially can cause disease.

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame.

    Do not use

    ■ in children less than 2 months of age

    ■ on open skin wounds

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

    When using this product

    • Do not get into eyes.

    Stop use and ask a doctor if

    • condition worsens
      • symptoms persist for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children.

    • . If product is swallowed, get medical help or contact a Poison Control Center immediately.
  • DIRECTIONS

    ■ Place enough product on hands to cover all surfaces. Rub hands together until dry.

    ■ Supervise children under 6 years of age when using this product to avoid swallowing.

  • OTHER INFORMATION

    ■ Store between 15-30C (59-86F)

    ■ Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENTS

    Water (Aqua), Aloe Barbadensis Leaf Juice*, Glycerin, Eucalyptus Globulus Oil*, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, FD&C Blue 1.

    *Certified organic

  • QUESTIONS OR COMMENTS?

    1-647-479-5525 or visit www.provinceapothecary.com

  • FRESH GEL HAND ANTISEPTIC CLEANER 250 mL (NDC 72257-250-00)

    Fresh Gel Hand Antiseptic Cleaner 250 mL

  • INGREDIENTS AND APPEARANCE
    FRESH HAND ANTISEPTIC CLEANER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72257-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    LAURETH-7 (UNII: Z95S6G8201)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72257-250-011 in 1 BOX05/28/2020
    1NDC:72257-250-00250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/28/2020
    Labeler - PROVINCE APOTHECARY INC (201115232)
    Registrant - PROVINCE APOTHECARY INC (201115232)