Label: HEB MAXIMUM STRENGTH PAIN RELIEF HEMORRHOIDAL- glycerin, petrolatum, phenylephrine hydrochloride, and pramoxine hydrochloride 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 October 22, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Glycerin 14.4%Protectant
    Petrolatum 15%Protectant
    Phenylephrine hydrochloride 0.25%Vasoconstrictor
    Pramoxine hydrochloride 1%Local Anesthetic
  • Uses

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

    For external use only.

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are 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 into rectum by using fingers or any mechanical device or applicator

    Stop use and ask a physician if

    • bleeding occurs
    • the condition worsens or does not improve within 7 days
    • an allergic reaction develops
    • the symptom being treated does not subside or redness, irritation, swelling, pain, or other symptoms develops, persists, 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: 800-222-1222.

  • Directions

    Adults:

    • when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying cream.
    • when first opening tube, remove foil seal
    • apply externally or in lower portion of anal canal only
    • apply externally to affected area up to 4 times daily, especially at night, in the morning, or after each bowel movement
    • for application in lower anal canal; remove cover from dispensing cap. Attach dispensing cap to tube. Lubriate dispensing cap well, then gently insert dispensing cap partway into anus
    • thoroughly cleanse dispensing cap after each use, and replace cover
    • Children under 12 years: ask a doctor
  • Other information

    • store at 15 to 30°C (59 to 86°F).
    • close cap tightly after use
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    aloe barbadensis leaf juice, BHA, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethylcellulose, steareth-2, steareth-20, stearyl alcohol, tocopherol (vitamin E) acetate, xanthan gum

  • Questions or comments?

    866-323-0107

  • PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

    Compare to Preperation H® Cream active ingredients*

    NDC 37808-992-24

    H-E-B®

    Maximum Strength Pain Relief
    Hemorrhoidal Cream
    Phenylephrine Hydrochloride / Vasoconstrictor • Pramoxine Hydrochloride / Local Anesthetic

    Hemorrhoid Symptom Relief

    With Soothing Aloe
    • Rapid, Soothing Pain Relief from Painful Burning, Itching and Discomfort
    • Shrinks Swollen Hemorrhoidal Tissue • Protects Irritated Tissue
    • Relieves External Discomfort

    Includes
    Dispensing
    Cap

    NET WT 2.0 OZ (56.7 g)

    Principal Display Panel - 56.7 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    HEB MAXIMUM STRENGTH PAIN RELIEF HEMORRHOIDAL 
    glycerin, petrolatum, phenylephrine hydrochloride, and pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-992
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.144 mg  in 2 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.15 mg  in 2 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.0025 mg  in 2 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE0.1 mg  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-23 (UNII: N72LMW566G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-992-241 in 1 CARTON10/18/2018
    156.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34610/18/2018
    Labeler - HEB (007924756)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(37808-992)
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