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Hemorrhoidal by Geritrex LLC

Medically reviewed on July 31, 2018

Dosage form: ointment
Ingredients: MINERAL OIL 7.98g in 57g, PETROLATUM 40.983g in 57g, PHENYLEPHRINE HYDROCHLORIDE 0.1425g in 57g
Labeler: Geritrex LLC
NDC Code: 54162-044

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.

Hemorrhoidal Ointment


Active Ingredient                    Purpose
Mineral Oil - 14%                   Protectant
Petrolatum - 71.9%              Protectant
Phenylephrine - 0.25%          Astringent

Uses:
  • Helps relieve local itching and discomfort with hemorrhoids.
  • Temporarily shrinks hemorrhoid tissues and relieves burning.
  • Temporarily provides a coating for relief of anorectal discomforts
  • Temporarily protects the inflamed, irritated anorectal surface to hlep make bowel movements less painful

Warnings:

For external and/or intrarectal use only

Ask a doctor before use if you have

  • Heart disease
  • Thyroid disease
  • Diabetes
  • High Blood pressure
  • Difficulty in urination due to enlargement of the prostate gland

Ask a doctor or a 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

Stop use and ask a doctor if:
  • Bleeding occurs
  • Condition worsens or does not improve within 7 days
  • Introduction of the applicator into the rectum causes additional pain

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.

Directions:
  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue.
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this ointment
  • Apply to affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.


For Intrarectal use

  • Remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert into the rectum.
  • Thoroughly cleanse applicator after each use
  • Also apply ointment to external area
  • Regular use provides continual therapy for relief of symptoms
  • Children under 12 years of age, consult a doctor

Other Information:

Store at room temperature but not over 80­° F
Lot No. & Exp Date: See tube

Inactive Ingredients:

Beeswax, benzoic acid, BHA, corn oil, glycern, lanolin alcohol, methyparaben, paraffin, propylparaben, shark liver oil, thyme, tocopherol, water.

HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-044
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL7.98 g  in 57 g
PETROLATUM (PETROLATUM) PETROLATUM40.983 g  in 57 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE0.1425 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
CORN OIL 
GLYCERIN 
LANOLIN ALCOHOLS 
METHYLPARABEN 
PARAFFIN 
PROPYLPARABEN 
SHARK LIVER OIL 
THYME 
TOCOPHEROL 
Packaging
#Item CodePackage Description
1NDC:54162-044-0257 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/31/2015
Labeler - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIOperations
Geritrex LLC112796248manufacture(54162-044)

 
Geritrex LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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