Label: NATUREPLEX HEMORRHOIDAL- witch hazel and phenylephrine hydrochloride gel

  • 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 December 5, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Phenylephrine HCl 0.25%Hemorrhoidal (anorectal) Gel
    Hamamelis Virginiana (witch hazel) 50%Hemorrhoidal (anorectal) Gel
  • Uses

    • temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorders
    • temporarily reduces the swelling associated with irriation in hemorrhoids and other anorectal disorders
    • temporarily shrinks hemorrhoidal tissue
    • aids in protecting irritated anorectal areas
    • temporary relief of burning
  • Warnings

    For external use only.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty urinating due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are taking a prescription drug for high blood pressure or depression

    When using this product

    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not put into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • bleeding occurs
    • the condition worsens or does not improve within 7 days. These may be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    Adults:

    • when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gel.
    • apply externally to affected area up to 4 times daily or after each bowel movement
    • Children under 12 years: ask a doctor
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • close cap tightly after use
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

  • Questions or comments?

    866-323-0107 or www.natureplex.com

  • PRINCIPAL DISPLAY PANEL - 25.5 g Tube Box

    NDC 67234-024-01

    Natureplex™

    Anesthetic
    HEMORRHOIDAL
    Cooling Gel With Soothing Aloe

    NET WT. 0.9 Oz.(25.5g)

    Fast Cooling Relief

    Principal Display Panel - 25.5 g Tube Box
  • INGREDIENTS AND APPEARANCE
    NATUREPLEX   HEMORRHOIDAL
    witch hazel and phenylephrine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.5 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.0025 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZOPHENONE (UNII: 701M4TTV9O)  
    HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-024-011 in 1 BOX03/18/2014
    125 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34603/18/2014
    Labeler - Natureplex LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-024)
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