Label: NEUTROGEL- soap 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 12, 2021

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Benzethonium chloride 0.10% w/w. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    • For washing sanitizing hands
    • Helps reduce bacteria on the skin that potentially can cause disease
  • Warnings

    For external use only.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product do not use

    • On children less than 2 months of age
    • On open skin wounds
  • STOP USE

    Stop use and ask a doctor if irritation or redness persists 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 as needed
    • Place enough product in your hand
    • Rub gently for at leats 30 seconds
    • Wash skin, rinse thoroughly and dry
  • Other information

    • Store at temperature below 110F (43C)
  • Inactive ingredients

    water, sodium lauryl ether sulfate, cocamidopropyl betaine, cocamide DEA, glycerin, propylene glycol, sodium chloride, citric acid, DMDM hydantoin

  • Package Label - Principal Display Panel

    (4000 mL)4000 mL NDC: 77251-008-01

    200000 mL NDC: 77251-008-02

    20000 mL NDC : 77251-008-03 20000 mL

    1000 mL NDC: 77251-008-04 1000 mL

    500 mL NDC: 77251-008-05 500 mL

    250 mL NDC: 77251-008-06 250 mL200000 mL

  • INGREDIENTS AND APPEARANCE
    NEUTROGEL 
    soap gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77251-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77251-008-014000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
    2NDC:77251-008-02200000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
    3NDC:77251-008-0320000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
    4NDC:77251-008-041000 mL in 1 POUCH; Type 0: Not a Combination Product03/30/2020
    5NDC:77251-008-05500 mL in 1 POUCH; Type 0: Not a Combination Product03/30/2020
    6NDC:77251-008-06250 mL in 1 POUCH; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - QUIMICA ROSMAR S.A DE C.V (814223475)
    Establishment
    NameAddressID/FEIBusiness Operations
    QUIMICA ROSMAR S.A DE C.V814223475manufacture(77251-008)
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