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Hemorrhoidal by Kareway Product, Inc.

Medically reviewed on July 2, 2018

Dosage form: ointment
Ingredients: MINERAL OIL 14g in 100g, PETROLATUM 71.9g in 100g, PHENYLEPHRINE HYDROCHLORIDE 0.25g in 100g
Labeler: Kareway Product, Inc.
NDC Code: 67510-0056

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 Facts

Uses
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue and relieves burning
  • 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
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or 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 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 wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment.
  • when first opening tube, puncture foil seal with top end of cap
  • apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • intrarectal use: remove cover form applicator and attach tube, lubricate applicator well, then gently insert applicator into the rectum - thoroughly cleanse applicator after each use and replace cover
  • also apply ointment to external area
  • regular use provides continual therapy for relief of symptoms
  • children under 12 years of age: ask a doctor

Other information

Other information

Store at 20o to 25oC (68o to 77oF)

Inactive ingredients

benzoic acid, butylated hydroxanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, shark liver oil, thyme oil, tocopherols excipient, white wax

Active ingredients

Mineral oil 14%

Petrolatum 71.9%

Phenylephrine HCL 0.25%

Purpose

Protectant

Protectant

Vasoconstrictor


Package labelPure-Aid Hemorrhoidal Ointment
HEMORRHOIDAL 
mineral oil,petrolatum,phenylephrine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0056
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL14 g  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM71.9 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
CORN OIL 
GLYCERIN 
LANOLIN 
LANOLIN ALCOHOLS 
METHYLPARABEN 
MINERAL OIL 
PARAFFIN 
PROPYLPARABEN 
WATER 
SHARK LIVER OIL 
THYME OIL 
WHITE WAX 
Packaging
#Item CodePackage Description
1NDC:67510-0056-21 TUBE (TUBE) in 1 CARTON
157 g in 1 TUBE
2NDC:67510-0056-11 TUBE (TUBE) in 1 CARTON
228 g in 1 TUBE
3NDC:67510-0056-61 TUBE (TUBE) in 1 CARTON
319 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/02/2012
Labeler - Kareway Product, Inc. (121840057)

 
Kareway Product, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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