Label: OLP HEMORRHOIDAL COOLING- phenylephrine hcl, witch hazel 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 November 26, 2018

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  • ACTIVE INGREDIENT

    Phenylephrine HCI, 0.25%

  • PURPOSE

    • 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 USING AND ASK YOUR DOCTOR IF

    • bleeding occurs
    • condition worsens or does not improve within 7 days
  • IF PREGNENT 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 20-25°C (68-77°F)

  • INACTIVE INGREDIENTS

    edetate disodium, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium metabisulphite

  • QUESTIONS

    ohiolabpharma.us

  • PACKAGE LABEL

    hemorrhoidal

    COOLING RELIEF
    OLP HEMORRHOIDAL COOLING GEL

  • INGREDIENTS AND APPEARANCE
    OLP HEMORRHOIDAL COOLING 
    phenylephrine hcl, witch hazel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70648-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE25 mg  in 1 g
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL500 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70648-009-011 in 1 CARTON02/01/2017
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34602/01/2017
    Labeler - OHIO LAB PHARMA (080215854)
    Registrant - OHIO LAB PHARMA (080215854)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHIO LAB PHARMA080215854manufacture(70648-009)
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