Label: AVEDANA HEMORRHOIDAL COOLING GEL- phenylephrine hcl, witch hazel gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 28, 2024

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  • ACTIVE INGREDIENTS

    Phenylephrine HCl 0.25%

    Witch hazel 50.0%

  • PURPOSES

    Vasoconstrictor

    Astringent

  • USES

    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporary relief of irritation and burning
    • temporarily shrinks hemorrhoidal tissue
    • aids in protecting irritated anorectal areas
  • WARNINGS

    For external use only

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    presently 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 this product into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens or does not improve within 7 days

    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.

  • DIRECTIONS

    • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying gel.
    • when first opening the tube, puncture foil seal with top end of cap
    • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    • children under 12 years of age: ask a doctor
  • OTHER INFORMATION

    store at 15°C - 30°C (59°F - 89°F)

  • INACTIVE INGREDIENTS

    aloe barbadensis leaf juice, edetate disodium, hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, sulisobenzone, vitamin E 

  • QUESTIONS OR COMMENTS?

    Call weekdays 8 AM to 5 PM EST at 1-724-733-7381

  • PRINCIPAL DISPLAY PANEL - TUBE LABEL

    Avedana®

    HEMORRHOIDAL COOLING GEL

    Fast Cooling
    Relief

    •Clear, Non-Greasy Formula with
    No Unpleasant Scent•Prompt, Cooling Relief from Painful
    Burning & Itching•Shrinks Swollen Hemorrhoidal Tissue•Relieves External Discomfort

    1 TUBE | 25.5 g | THIS PACKAGE CONTAINS AN OUTER CARTON. DO NOT BUY IF OUTER CARTON IS MISSING.

    PRINCIPAL DISPLAY PANEL - 25.5 g Tube Label

  • PRINCIPAL DISPLAY PANEL - CARTON LABEL

    Avedana ®

    HEMORRHOIDAL COOLING GEL

    Fast Cooling
    Relief

    •Clear, Non-Greasy Formula with
    No Unpleasant Scent•Prompt, Cooling Relief from Painful
    Burning & Itching•Shrinks Swollen Hemorrhoidal Tissue•Relieves External Discomfort

    1 TUBE INSIDE CARTON | NET WT 0.9 OZ (25.5 g)

    PRINCIPAL DISPLAY PANEL - 25.5 g Carton Label

  • INGREDIENTS AND APPEARANCE
    AVEDANA HEMORRHOIDAL COOLING GEL 
    phenylephrine hcl, witch hazel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-450
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL500 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43749-450-011 in 1 CARTON01/01/2004
    125.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01501/01/2004
    Labeler - Unipack LLC (009248480)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack LLC009248480manufacture(43749-450)
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