Label: MAKESENSE- phenylephrine hydrochloride zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 11, 2014

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  • 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)