Label: BIOARMOUR HAND SANITIZER SQUEEZE HOSE- 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 May 11, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70% Purpose: Antimicrobial

  • Purpose

    Antimicrobial

  • Uses

    Use(s)

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use
  • Warnings

    Warnings

    For external use only. Flammable, keep away from heat and flame.

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

  • STOP USE

    • Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Wet hands thoroughly with product
    • Briskly rub hands together until dry
    • Supervise children under 6 years in the use of this product
  • Other information

    • Store at 20 oC to 25 oC (68 o to 77 oF)
    • May discolor certain fabrics
  • Inactive ingredients

    Water (aqua), Triethanolamine, Carbomer, Propylene Glycol, Glycerin, Aloe Barbadensis Extract, Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    BIOARMOUR HAND SANITIZER  SQUEEZE HOSE
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75738-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75738-011-0130 mL in 1 TUBE; Type 0: Not a Combination Product04/28/2020
    2NDC:75738-011-0260 mL in 1 TUBE; Type 0: Not a Combination Product04/28/2020
    3NDC:75738-011-0380 mL in 1 TUBE; Type 0: Not a Combination Product04/28/2020
    4NDC:75738-011-04100 mL in 1 TUBE; Type 0: Not a Combination Product04/28/2020
    5NDC:75738-011-05120 mL in 1 TUBE; Type 0: Not a Combination Product04/28/2020
    6NDC:75738-011-06150 mL in 1 TUBE; Type 0: Not a Combination Product04/28/2020
    7NDC:75738-011-07180 mL in 1 TUBE; Type 0: Not a Combination Product04/28/2020
    8NDC:75738-011-08200 mL in 1 TUBE; Type 0: Not a Combination Product04/28/2020
    9NDC:75738-011-09250 mL in 1 TUBE; Type 0: Not a Combination Product04/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/28/2020
    Labeler - Ningbo Unice Houseware Co., Ltd. (412924089)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pretty Tourism Manufacturer Co. Ltd.553193489manufacture(75738-011)
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