Label: LEADER- phenylephrine hydrochloride and witch hazel cream

  • Category: HUMAN OTC DRUG LABEL

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 January 24, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Phenylephrine hydrochloride 0.25%

    Witch hazel 50.0%

  • PURPOSE

    Vasoconstrictor

    Astringent

  • Uses

    • temporarily relieves irritation and burning
    • helps relieve the local itching and discomfort associated with hemorrhoids
    • 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
    • diabetes
    • thyroid disease
    • trouble urinating due to an enlarged 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
    • 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 occur
    • condition gets worse 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 and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or 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 at20°-25°C (68°-77°F)
    • for lot number and expiration date, see crimp of tube or see box
  • Inactive ingredients

    aloe barbadensis leaf juice, disodium EDTA, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, tocopheryl acetate (Vitamin E)

  • Principal Display Panel - Carton Label

    NDC 49781-091-01

    LEADER®

    Hemorrhoidal Cooling Gel

    Relief from intense burning & itching

    Relieves external discomfort

    Enriched with Aloe

    NET WT 0.9 OZ (26g)

    Principal Display Panel - Carton Label
  • INGREDIENTS AND APPEARANCE
    LEADER 
    phenylephrine hydrochloride and witch hazel cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-091
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride2.5 mg  in 1 L
    witch hazel (UNII: 101I4J0U34) (witch hazel - UNII:101I4J0U34) witch hazel500 mg  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    edetate disodium (UNII: 7FLD91C86K)  
    hydroxyethyl cellulose (100 mpa.s at 2%) (UNII: R33S7TK2EP)  
    methylparaben (UNII: A2I8C7HI9T)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49781-091-011 in 1 CARTON04/28/2014
    10.026 L in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/28/2014
    Labeler - Cardinal Health (097537435)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Essentials947484713MANUFACTURE(49781-091)
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