Label: HEB HEMORRHOIDAL COOLING GEL- witch hazel and phenylephrine 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 23, 2018

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Hamamelis virginiana (witch hazel) 50%Astringent
    Phenylephrine hydrochloride 0.25%Vasoconstrictor
  • Uses

    • temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorders
    • temporarily reduces the swelling associated with irriation in hemorrhoids and other anorectal disorders
    • temporarily shrinks hemorrhoidal tissue
    • aids in protecting irritated anorectal areas
    • temporary relief of burning
  • Warnings

    For external use only.

    Do not use this product

    • if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

    Ask a doctor or pharmacist before use if you are

    • presently taking a prescription drug for high blood pressure of depression.

    When using this product

    • do not exceed 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 doctor if

    • condition worsens or does not improve within 7 days
    • bleeding occurs

    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 gel
      • apply externally to affected area up to 4 times daily or after each bowel movement
    • Children under 12 years old: Ask a doctor
  • Other information

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

    Aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

  • Questions or comments?

    866-323-0107

  • PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

    Compare to Preperation H® Hemorrhoidal Cooling Gel active ingredients*

    NDC 37808-993-24

    H-E-B®

    Hemorrhoidal Cooling Gel
    Hamamelis Virginiana (Witch Hazel) / Astringent • Phenylephrine Hydrochloride / Vasoconstrictor

    Hemorrhoid Symptom Relief

    With Soothing Aloe

    • Clear, Non-Greasy Formula with a Pleasant Scent
    • Prompt Cooling Relief from Painful Burning and Itching
    • Shrinks Swollen Hemorrhoidal Tissue • Relieves External Discomfort

    NET WT 0.9 OZ (26 g)

    Principal Display Panel - 26 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    HEB HEMORRHOIDAL COOLING GEL 
    witch hazel and phenylephrine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-993
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.5 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.0025 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-993-241 in 1 CARTON10/18/2018
    126 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(37808-993)
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!