Label: HEMORRHOID RELIEF- glycerin, lidocaine, phenylephrine hcl and white petrolatum cream

  • 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 12, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    GlycerinProtectant
    LidocaineLocal anesthetic
    Phenylephrine HCl

    Vasoconstrictor
    White PetrolatumProtectant
  • INDICATIONS & USAGE

    Uses

    • for temporary relief of pain, soreness and burning
    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporarily provides a coating for relief of anorectal discomforts
    • temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful
  • WARNINGS

    Warnings

    For external use only

    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

    • rectal bleeding occurs
    • condition worsens or does not improve within 7 days
    • an allergic reaction develops
    • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

    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.

  • DOSAGE & ADMINISTRATION

    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 this cream.
    • 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
  • STORAGE AND HANDLING

    Other information

    store at 20–25°C (68–77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera gel, benzyl alcohol, butylated hydroxy toluene, carboxymethylcellulose sodium, cetomacrogol 1000, cetyl alcohol, cetyl alcohol, citric acid, disodium EDTA, glyceryl monostearate, light liquid paraffin, propylene glycol, purified water, stearyl alcohol, Vitamin E, xanthan gum

  • QUESTIONS

    Questions or comments?

    Call 1-855-314-1850

  • Package Label

    11

  • INGREDIENTS AND APPEARANCE
    HEMORRHOID RELIEF 
    glycerin, lidocaine, phenylephrine hcl and white petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0746
    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
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0746-21 in 1 CARTON10/25/2020
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34610/25/2020
    Labeler - Rite Aid Hdgrts Corp (014578892)
    Registrant - Velocity Pharma LLC (962198409)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!