SANIGUARD-SF (ALCOHOL) LIQUID [INOPAK. LTD]

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SANIGUARD-SF (ALCOHOL) LIQUID [INOPAK. LTD]
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NDC 58575-150-02, 58575-150-10, 58575-150-12, 58575-150-18, 58575-150-37, 58575-150-80
Set ID f05b8a05-1eb8-4734-90e0-9948e685854c
Category HUMAN OTC DRUG LABEL
Packager Inopak. Ltd
Generic Name
Product Class
Product Number
Application Number PART333E
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Alcohol 70% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • For handwashing to decrease bacteria on the skin after changing diapers, assisting ill persons or before contact with a person under medical care or treatment.
    • Recommended for repeated use.
  • WARNINGS

    Warnings

    For external use only. Flammable, keep away from fire or flame.

    When using this product keep away from eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally to hands to cover all surfaces.
    • Rub hands together until dry.
    • Supervise children under 6 years old.
    • Not recommended for infants.
  • INACTIVE INGREDIENT

    Inactive ingredients Benzalkonium Chloride, Chlorhexidine Gluconate, Isopropyl Alcohol, PEG-10 Dimethicone, PEG-14M, Phenoxyethanol, Polyquaternium 10, Water.

  • SPL UNCLASSIFIED SECTION

    Inopak, LTD. Ringwood, NJ 07456 • 1-800-762-7725 • www.inopak.com

  • PRINCIPAL DISPLAY PANEL

    SaniGuard SF

    foam hand sanitizer

    alcohol 70%

    Compliant with CDC Hand Hygiene Guidlines

    Does not contain DEA/MEA, triclosan, parabens, formaldehyde, dyes, fragrance

    33.8 fl. oz. (1000 mL)

    SaniGuard_ 1000mL Apr 2021

  • INGREDIENTS AND APPEARANCE
    SANIGUARD-SF 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-150
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 600000 (UNII: 2126FD486L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58575-150-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/201104/20/2021
    2NDC:58575-150-80800 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2011
    3NDC:58575-150-101000 mL in 1 BAG; Type 0: Not a Combination Product05/01/201104/20/2021
    4NDC:58575-150-121250 mL in 1 BAG; Type 0: Not a Combination Product05/01/201104/20/2021
    5NDC:58575-150-373840 mL in 1 BAG; Type 0: Not a Combination Product05/01/201104/20/2021
    6NDC:58575-150-18540 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2011
    7NDC:58575-150-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2021
    8NDC:58575-150-011000 mL in 1 POUCH; Type 0: Not a Combination Product04/20/2021
    9NDC:58575-150-423800 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2011
    Labeler - Inopak. Ltd (194718243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inopak. Ltd194718243manufacture(58575-150)
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