MAKESENSE (PHENYLEPHRINE HYDROCHLORIDE ZINC OXIDE) CREAM [CHERRY HILL SALES CO]

MAKESENSE (PHENYLEPHRINE HYDROCHLORIDE ZINC OXIDE) CREAM [CHERRY HILL SALES CO]
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NDC 69020-205-28
Set ID 2d69b75e-55e0-49f5-8646-8befcc941b0a
Category HUMAN OTC DRUG LABEL
Packager Cherry Hill Sales Co
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
  • Active Ingredient

    Phenylephrine HCL 0.25%

    Zinc Oxide 12.50%

  • Purpose

    Vasoconstrictor

    Astringent

  • Uses

    For temporary relief of local anorectal burning and discomfort associated with hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles.

  • Warnings

    For external use only

  • Do not use

    ■ on children under 2 years of age except under the advise and supervision of a doctor ■ for diaper rash

  • Stop use and ask a doctor if

    ■ condition worsens or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ Do not exceed the recomended daily dosage unless directed by a doctor ■ In case of bleeding, consult a doctor promptly ■ Certain persons can develop allergic reactions to ingredients in this product ■ If the symptom treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult doctor ■ If you are pregnant, do not use this product without first consulting doctor.

  • Keep out of reach of children

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

  • Directions

    ■ Cleanse affected area with mild soap and warm water, rinse thorouhly ■ Dry by patting or blotting with toilet tissue
    or soft cloth before applying ■ Cover the entire affected area with a thin layer 1 to 3 times daily ■ Children under 12 years of age need
    to consult doctor before using this product

  • Other information

    ■ store at 68-77F (20 to 25C) ■ See Lot No. and Exp. Date: on box and crimp of tube

  • Inactive Ingredients

    Lanolin, Methylparaben, Ozokerite, Paraffin, Propylparaben, White Petrolatum

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    MAKESENSE 
    phenylephrine hydrochloride zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CERESIN (UNII: Q1LS2UJO3A)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69020-205-2828 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/31/2014
    Labeler - Cherry Hill Sales Co (145959768)

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