Label: ALCOHOL PAD 01- alcohol cloth

  • NDC Code(s): 82953-012-01
  • Packager: Cosmuses Cosmetics (Ningbo) Co., Ltd.
  • 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 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Fact

  • Active Ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    for preparation of the skin prior to injection.

  • Warnings

    • For external use only.
    • Flammable, keep away from fire or flame.

    Do not use

    • with electrocautery procedures.
    • in the eyes.

    Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.

    Keep out of reach of children if swallowed, get medical help or contact a poison control center right away.

  • Directions

    Wipe injection site vigorously and discard.

  • Inactive Ingredients

    Purified Water

  • STORAGE AND HANDLING

    other information

    store at room temperature: 15℃-30℃ (59℉-86℉)

  • PRINCIPAL DISPLAY PANEL

    82953-012

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PAD  01
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82953-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82953-012-011 in 1 BAG; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug08/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/24/2023
    Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
    Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmuses Cosmetics (Ningbo) Co., Ltd.725290934manufacture(82953-012)
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