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Purely Sanitizer by King Pharma

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Purely Sanitizer by King Pharma

Medically reviewed by . Last updated on Apr 20, 2020.

Dosage form: gel
Ingredients: ALCOHOL 65mL in 100mL
Labeler: King Pharma
NDC Code: 74858-201

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (65%, weight/weight (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (1.5% w/w).
  • Hydroxypropyl Cellulose (1.1% w/w).
  • Lauryl Lactate (1.0% w/w).
  • 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)

    Alcohol 65% w/w. Purpose: Antiseptic

    Purpose

    Antiseptic, Hand Sanitizer

    Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

    Warnings

    For external use only. Flammable. Keep away from heat or flame

    Do not use
    • in children less than 2 months of age
    • on open skin wounds

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

    Directions
    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

    Other information
    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)

    Inactive ingredients

    glycerin, hydroxypropyl cellulose, lauryl lactate, purified water USP

    Package Label - Principal Display Panel

    118.3 mL NDC: 74858-201-04

    PURELY SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74858-201
    Route of AdministrationTOPICALDEA Schedule    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (ALCOHOL) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED1.1 mL  in 100 mL
    LAURYL LACTATE1 mL  in 100 mL
    GLYCERIN1.5 mL  in 100 mL
    WATER 
    LIMONENE OXIDE, (+)-0.5 mL  in 100 mL
    Packaging
    #Item CodePackage Description
    1NDC:74858-201-04118.3 mL in 1 BOTTLE, PLASTIC
    2NDC:74858-201-08236.6 mL in 1 BOTTLE, PLASTIC
    3NDC:74858-201-383785.4 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/16/2020
    Labeler - King Pharma (104697470)
    Establishment
    NameAddressID/FEIOperations
    King Pharma104697470manufacture(74858-201)

    Document Id: a3be581e-bfac-0a61-e053-2995a90a9440 Set id: a36eb4cc-32dd-44cf-e053-2995a90a320a Version: 2 Effective Time: 20200420  King Pharma

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