Label: ALCOHOL WET WIPES- ethyl alcohol swab

  • 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 August 12, 2020

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

  • Active ingredient

    Ethy| Alcohol 75%

    Purpose

    Antiseptic

  • Use

    Sanitizes Hands.

  • Warnings

    ●FOR EXTERNAL USE ONLY.
    ●HIGHLY FLAMMABLE. Keep away from fire or flame.
    。Harmful if swallowed.
    ●Do not eat or drink when handling.
    ●Avoid contact with open or exposed wounds.
    ●Do not use as baby wipes.
    ●Keep away from heat, hot surfaces, sparks, open flames and other ignition surfaces. No smoking.
    .DO NOT FLUSH DOWNTHE TOILET. .In case of fire use water spray, carbon dioxide, dry chemical powder, or aprpiater foam.
    Do Not Use
    HAZARD TO HUMANS AND DOMESTIC ANIMALS:
    Skin rritation is not expected. Should iritation develop, wash affected area with soap and discontinue use. Causes mild eye irition.
    Immediately fush with water for at least 15 minutes, lifting lower and upper eyelids occasionally.

    Stop Use
    Normal use of this product does not pose an inhalation hazard should respiratory tract iritation develop, discontinue use and seek fresh air.
    Seek medical attention if any of the stated above iritations or other symptoms persist. DO NOT ingest. Seek medical attention immediately.

    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

    ●Lift the tab on the top of the lid to open.
    ●Close the lid to retain moisture.
    ●Open moisture seal film package before use.
    ●Wipe clean with this product. Let air dry.
    ●Pull out first wipe through the dispensing center of the canister. Next sheet pops up automatically.

  • INACTIVE INGREDIENT

    Aqua (Purified Water)

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WET WIPES 
    ethyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71198-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71198-003-10160 in 1 BOTTLE06/02/2020
    11.62 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:71198-003-01100 in 1 BOTTLE06/02/2020
    21.62 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:71198-003-0250 in 1 PACKAGE06/02/2020
    31.62 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:71198-003-0380 in 1 PACKAGE06/02/2020
    41.62 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:71198-003-04100 in 1 PACKAGE06/02/2020
    51.62 g in 1 POUCH; Type 0: Not a Combination Product
    6NDC:71198-003-051200 in 1 PACKAGE06/02/2020
    61.62 g in 1 POUCH; Type 0: Not a Combination Product
    7NDC:71198-003-0610 in 1 PACKAGE06/02/2020
    71.62 g in 1 POUCH; Type 0: Not a Combination Product
    8NDC:71198-003-0760 in 1 PACKAGE06/02/2020
    81.62 g in 1 POUCH; Type 0: Not a Combination Product
    9NDC:71198-003-0875 in 1 BOTTLE06/02/2020
    91.62 g in 1 POUCH; Type 0: Not a Combination Product
    10NDC:71198-003-0960 in 1 BOTTLE06/02/2020
    101.62 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/02/2020
    Labeler - HANGZHOU BRIGHT DAILY CHEMICAL CO.,LTD (543255067)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANGZHOU BRIGHT DAILY CHEMICAL CO.,LTD543255067manufacture(71198-003)