Label: SOFT N SURE ANTISEPTIC HAND- 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 22, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl alcohol 65%

  • Purpose

    Antiseptic

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
  • Warnings

    For external use only: hands

    Flammable. Keep away from fire or flame.

    When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water
    • avoid contact with broken skin
    • do not inhale or ingest

    Stop use and ask a doctor if

    • irritation and redness develop.
    • condition persists more than 72 hours

    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 and allow to dry without wiping
    • for children under 6, use under adult supervision
    • not recommended for infants
  • Other information

    • do not store above 105°F
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive Ingredients

    benzophenone-4, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, water

  • Questions or comments?

    1-866-783-0422

  • PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label

    SCJ PROFESSIONAL
    HEALTHCARE

    Soft 'N Sure®

    NDC 11084-812-21

    Hand Sanitizer
    Antiseptic Hand Gel

    Moisturizing

    15
    seconds
    Fast-Acting

    Manufactured for:
    SC Johnson Professional USA, Inc.
    Charlotte, NC 28217
    1-866-783-0422
    www.scjp.com
    Pat. www.scjp.com/patents

    deb
    SKIN CARE

    1 Liter (33.8 fl oz) (1.05 qt)
    SAP # 4000000065

    REORDER #
    1445-87

    1445-86H(F)(118)

    PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label
  • INGREDIENTS AND APPEARANCE
    SOFT N SURE ANTISEPTIC HAND 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-812
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SULISOBENZONE (UNII: 1W6L629B4K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    ACETATE ION (UNII: 569DQM74SC)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-812-411000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2018
    2NDC:11084-812-13444 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/201803/31/2022
    3NDC:11084-812-21946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/201803/31/2022
    4NDC:11084-812-2559 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/201801/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/01/2018
    Labeler - SC Johnson Professional USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668MANUFACTURE(11084-812)
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