Label: HAND SANITIZER- 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 June 10, 2020

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  • Active ingredient

    Ethyl alcohol v/v - 70%

  • Purposes

    Antimicrobial

  • Uses

    - Hand sanitizer to decrase bacteria on the skin that could cause disease

    - Recommended for repeted use

  • Warnings

    For external use only: hands

    Flammable, keep away form fire or flame

  • When using this product

    keep out of eyes, do not use in or near the eyes

    -in case of contact eyes, flush thorougly with water

    -Avoid contact with broken skin

    -Do not inhale or ingest

  • When using this product

    keep out of eyes, do not use in or near the eyes

    -in case of contact eyes, flush thorougly 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 for more than 72 hours

  • keep out of reach of children

    if swallowed, get medical help or contact a posion center right away

  • directions

    -Put enough product in your palm to cover hands and rub hands together briskly until dry without wiping

    -For children under 6 years of age should be supervised when using

    -Not recommended for infants

  • Other information

    - Store below 105 F (40 C)

    - May discolor certain fabrics

    - Harmful to wood finishes and plastics

  • Inactive ingredients

    Purified water (aqua), Vegetable glycerin and carboxymethyl cellulose and hydroxypropyl methylcellulose HPMC

  • QUESTION OR COMMENTS

    CALL: 956 999 5319

    visit www.phiimportingcompany.com

  • PRINCIPAL DISPLAY

    label 250 ml hand sanitizer

    desifectante para manos

    kills 99.9% of most germs

    elima el 99.9% de la mayoria de germenes

    70% alcohol volume

    non sterile solution

    8.5 fl oz (250 ml )

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77210-0007
    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
    HYPROMELLOSE 2208 (60000 MPA.S) (UNII: 2F7T07H9ZD) 0.1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 29.6 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.2 mL  in 100 mL
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) 0.1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77210-0007-1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/10/2020
    Labeler - EXPORTADORA IN & OUT S DE RL DE CV (951577298)
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