Label: TOPWIN SPEEDY ENEMA- glycerin enema

  • NDC Code(s): 73513-323-20
  • Packager: Health Chemical Pharmaceutical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 22, 2023

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  • Active Ingredient

    Glycerin  3g       

  • Purpose

    Glycerin     Hyperosmotic Laxative

  • Uses

    For relief of occasional constipation

  • Warnings

    For rectal use only

  • Do not use

    when rectal irritation, abdominal pain, nausea, fever, or vomiting are present unless directed by a doctor.

  • Ask a doctor before using any laxative if you have

    • a sudden change in bowel habits lasting more than 2 weeks
    • already used a laxative for more than 1 week
  • Stop using and ask a doctor if you have

    • rectal discomfort
    • burning sensation
    • rectal bleeding
    • no bowel movement within 1 hour of using this product
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Single Daily Usage (per 24 hours)
    • Adults and children, 6 years and over: 20 ml / 3g Glycerin or as directed by a doctor
    • Children 3-6 years: 10 ml / 1.5g Glycerin or as directed by a doctor
    • Knee-chest / Upright position: Lubricate anus with petroleum jelly first, gently insert tip of the enema applicator into the rectum with a single side to side movement to prevent damage to the rectal wall, allow 15 minutes to 1 hour to produce bowel movement. Discard unit after use. No left fluid should be re-used.

  • Other Information

    Store below 77°F (25 °C) in a cool dry place and protected from sunlight. Do not use if cap is broken.

  • Inactive Ingredients

    Methylparaben, Sodium Chloride, Sodium Benzoate, Water

  • Questions?

    Manufactured by Health Chemical Pharmaceutical Co, Ltd
    Made in Taiwan

    U.S. Importer: Larkin Inc. dba Asia Company
    1695 Jerrold Avenue, San Francisco, CA 94124
    Email: info@larkinin-us.com
    Phone: (415)285-8888

  • Topwin Speedy Enema  NDC 73513-323-20

    image description

  • INGREDIENTS AND APPEARANCE
    TOPWIN SPEEDY ENEMA 
    glycerin enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73513-323
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73513-323-205 in 1 BOX05/28/2020
    12 in 1 PACKET
    120 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00705/28/2020
    Labeler - Health Chemical Pharmaceutical Co., Ltd (656344421)
    Registrant - Health Chemical Pharmaceutical Co., Ltd (656344421)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health Chemical Pharmaceutical Co., Ltd656344421manufacture(73513-323)
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