Label: PRISTINE1- 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 1, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antimicrobial

    active

  • Purpose

    Antimicrobial purpose, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria on skin

    Use

  • Warnings

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

  • Do not use

    When using this product do not use in or near the eyes. In case of contact, flush thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts.

    dont use

  • WHEN USING

    When using this product do not use in or near the eyes. In case of contact, flush thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts.

    When

  • STOP USE

    When using this product do not use in or near the eyes. In case of contact, flush thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts.

    stop

  • 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.

    keep

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using.

    dosage

  • Other information

    • STORE BELOW 110F. May discolor sorne fabrics and surfaces.
    • storage
  • Inactive ingredients

    Water, triethanolamine, Carbomer, Aloe vera extract, phenoxyethanol

    inactive

  • Package Label - Principal Display Panel

    Hand Sanitizer Gel with Aloe Vera

    Kills 99.9% of Germs

    front

  • INGREDIENTS AND APPEARANCE
    PRISTINE1 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77605-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK) 0.055 mL  in 1 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.002 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.45 mL  in 1 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.006 mL  in 1 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.001 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77605-110-01325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    2NDC:77605-110-023785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Caribbean Spirit Imports LLC (044842772)
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Safety

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Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

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