Label: DCH RAPID RELIEF HEMORRHOIDAL- lidocaine 5%, phenylephrine hydrochloride 0.25% spray

  • NDC Code(s): 72839-263-05
  • Packager: Derma Care Research Labs
  • 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 July 20, 2023

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  • ACTIVE INGREDIENT

    Lidocaine 5%, Phenylephrine HCl 0.25%,

  • PURPOSE

    Topical Anesthetic, Vasoconstrictor

  • INDICATIONS & USAGE

    Helps relieve the local itching and discomfort associated with anorectal disorders or inflammation.

  • WARNINGS

    For external use only.

    Flammable--do not use while smoking or near heat or flame.

    When using this product avoid contact with eyes, contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F, do not exceed recommended daily dosage unless directed by a doctor, do not put this product in the rectum by using fingers or any mechanical device or applicator.

    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, presently taking a prescription for high blood pressure or depression.

    Stop use and ask a doctor if rectal bleeding occurs, the condition worsens or symptoms does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

    Ask a healthcare or professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, seek medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    When practical, cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently pat dry. Spray the affected area, wash hands after applying. Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor.

  • INACTIVE INGREDIENT

    Alcohol, Aloe Barbadensis Leaf Extract, Citric Acid, Disodium EDTA, Glycerin, Malic Acid, Menthol, Propyl Gallate, Propylene Glycol, Sodium Benzoate, Water.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    DCH RAPID RELIEF HEMORRHOIDAL 
    lidocaine 5%, phenylephrine hydrochloride 0.25% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-263
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    MENTHOL (UNII: L7T10EIP3A)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALIC ACID (UNII: 817L1N4CKP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-263-05142 g in 1 CAN; Type 0: Not a Combination Product02/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34602/24/2023
    Labeler - Derma Care Research Labs (116817470)
    Registrant - Derma Care Research Labs (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs116817470manufacture(72839-263)