Label: FRESHQUITAS ANTISEPTIC HAND WIPES- alcohol cloth

  • 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 February 11, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    This is a package of hand sanitizer wipes containing the following ingredients:

    1. Alcohol (ethanol) (70% volume/volume (v/v)).
    2. Aqua
    3. Propylene Glycol,
    4. Phenoxyethanol, PEG-40
    5. Hydrogenated Castor Oil
    6. PEG-12 Dimethicone
    7. Prunus Amygdalus Dulcis (Sweet Almond) Oil
    8. Edetate Disodium

    The firm does not add other active or inactive ingredients.

  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic Hand Wipes

  • Use

    • For hand washing to decrease bacteria on the skin disease
    • Recommended for repeated use
  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    Allergy Alert: Contains Almond Oil.

  • WHEN USING

    When using this product:

    • avoid contact with eyes, ears, and mouth. If contact occurs with eyes, flush thoroughly with water
    • avoid contact with broken skin
    • avoid inhalation
    • if inhaled for prolonged period, seek immediate medical attention
  • STOP USE

    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

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

  • Do not use

    • in children less than 2 months of age
    • if you are allergic to any ingredients
    • on open skin wounds
  • Directions

    • Remove wet wipe and apply thoroughly to hands as desired
    • Allow to dry without wiping
    • Supervise children in the use of this product
    • Use only as directed.
  • Other information

    • Store between 59-86°F
    • Keep sealed after between uses
    • Avoid freezing and heat above 104°F
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Aqua, Propylene Glycol, Phenoxyethanol, PEG-40 Hydrogenated Castor Oil, PEG-12 Dimethicone, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Edetate Disodium

  • Package Label - Principal Display Panel

    10 Wipes NDC: 79089-501-01

    Freshquitas 10 Wipes

    40 Wipes NDC: 79089-501-02

    Freshquitas 40 Wipes

    150 Wipes NDC: 79089-501-03

    Freshquitas 150 Wipes

  • INGREDIENTS AND APPEARANCE
    FRESHQUITAS ANTISEPTIC HAND WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79089-501
    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
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79089-501-0110 in 1 PACKAGE03/01/2021
    132 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:79089-501-0240 in 1 PACKAGE03/01/2021
    2110 mL in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:79089-501-03150 in 1 PACKAGE03/01/2021
    3411 mL in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2021
    Labeler - Carmel Industria e Comercio de Produtos de Higiene e Limpeza Ltda (903638113)
    Registrant - Carmel Industria e Comercio de Produtos de Higiene e Limpeza Ltda (903638113)
    Establishment
    NameAddressID/FEIBusiness Operations
    Carmel Industria e Comercio de Produtos de Higiene e Limpeza Ltda903638113manufacture(79089-501)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!