FULL CARE ALCOHOL SWABSTICKS (ISOPROPYL ALCOHOL) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]

FULL CARE ALCOHOL SWABSTICKS (ISOPROPYL ALCOHOL) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]
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NDC 65028-003-01, 65028-003-02, 65028-003-03
Set ID b83a00cf-3189-4675-8f4b-1867fdc69351
Category HUMAN OTC DRUG LABEL
Packager Shaoxing Fuqing Health Products Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART333A
  • ACTIVE INGREDIENT

    Active Ingredient: Isopropyl Alcohol (70%)

  • PURPOSE

    Purpose: Antiseptic

  • INDICATIONS & USAGE

    Use:

    For use where topical defatting or cleasing is required.

  • WARNINGS

    Warnings:

    For external use only

    Flammable. Keep away from fire or flame

    Do not use:

    With electrocautery procedures

    In the eyes. If contact occurs, flush eyes with water.

  • ASK DOCTOR

    Stop use:

    If irritation or redness develop

    If condition persists consult your healthcare practitioner

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions:

    Apply to intended area as needed.

    Discard after single use.

  • STORAGE AND HANDLING

    Other Information:

    • Store at room temperature
    • Avoid excessive heat (above 104F or 40C)
    • Protect from freezing
    • Latex free
  • INACTIVE INGREDIENT

    Inactive Ingredient

    Purified water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FULL CARE ALCOHOL SWABSTICKS 
    isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65028-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL1.4 g  in 2 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65028-003-018 mL in 1 POUCH
    2NDC:65028-003-022.5 mL in 1 POUCH
    3NDC:65028-003-036 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/22/2014
    Labeler - Shaoxing Fuqing Health Products Co., Ltd. (530545003)
    Registrant - Shaoxing Fuqing Health Products Co., Ltd. (530545003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shaoxing Fuqing Health Products Co., Ltd.530545003manufacture(65028-003)

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