Label: SANIGUARD-SF- alcohol liquid

  • 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 June 30, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Alcohol 70% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • 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 heat or flames.

    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, contact a physician or poison control center.

  • 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 Water, PEG-10 Dimethicone, Glycerin, Isopropyl Myristate, Polyquaternium-11, Disodium EDTA, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate

  • SPL UNCLASSIFIED SECTION

    Manufacturd for

    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

    NET CONTENTS: 33.8 FL. OZ. (1000 ML)

    58575-150 SaniGuard HS-0622

  • 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
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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)