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SHOPKO HEMORRHOIDAL by UNITED EXCHANGE CORP.

Dosage form: ointment
Ingredients: MINERAL OIL 140mg in 1g, PETROLATUM 719mg in 1g, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1g, SHARK LIVER OIL 30mg in 1g
Labeler: UNITED EXCHANGE CORP.
NDC Code: 65923-777

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 and/or intrarectal 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 now taking a prescription drug for high blood pressure or depression

When using this product do not use more than the recommended daily dosage

Stop use and ask a doctor if

  • bleeding occurs
  • condition gets worse or does not get better within 7 days
  • introduction of the applicator into the rectum causes additional pain

If pregnant or breast-feeding, ask a physician before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • children under 12 years of age: ask a doctor
  • 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
  • when first opening tube, remove foil seal
  • for intrarectal use: remove protective cover form applicator and attach to tube
  • lubricate applicator well, then gently insert applicator into the rectum
  • thoroughly clean applicator and replace protective cover after each use
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • also apply ointment to external area

Other information

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

Inactive ingredients

benzoic acid, BHA, BHT, methylparaben, paraffin, propylparaben, thyme oil, glyceryl stearate, glycerin, absorb refined lanoline, purified water

Distributed by

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

www.ueccorp.com

Made in Korea

Active ingredients                                                              Purpose

Mineral oil 14% .................................................................Protectant

Petrolatum 71.9% .............................................................Protectant

Phenylephrine HCL 0.25% .................................................Vasoconstrictor

Shark liver oil 3.0% ...........................................................Protectant

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SHOPKO HEMORRHOIDAL 
mineral oil,petrolatum,phenylephrine,shark liver oil ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-777
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL140 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM719 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
SHARK LIVER OIL (SHARK LIVER OIL) SHARK LIVER OIL30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
BUTYLATED HYDROXYTOLUENE 
METHYLPARABEN 
PARAFFIN 
PROPYLPARABEN 
THYME OIL 
WATER 
Packaging
#Item CodePackage Description
1NDC:65923-777-881 TUBE (TUBE) in 1 CARTON
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/21/2011
Labeler - UNITED EXCHANGE CORP. (840130579)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIOperations
TAI GUK PHARM. CO., LTD631101656manufacture

Revised: 03/2011
 
UNITED EXCHANGE CORP.

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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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