SHOPKO HEMORRHOIDAL- mineral oil,petrolatum,phenylephrine,shark liver oil ointment

SHOPKO HEMORRHOIDAL by

Drug Labeling and Warnings

SHOPKO HEMORRHOIDAL by is a Otc medication manufactured, distributed, or labeled by UNITED EXCHANGE CORP., TAI GUK PHARM. CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

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

Warnings

For external and/or intrarectal use only

ASK DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are now taking a prescription drug for high blood pressure or depression

WHEN USING

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

STOP USE

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
  

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

INDICATIONS & USAGE

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
  

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

Distributed by

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

www.ueccorp.com

Made in Korea

ACTIVE INGREDIENT

Active ingredients                                                              Purpose

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

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

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

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

SHOPKO HEMORRHOIDAL 
mineral oil,petrolatum,phenylephrine,shark liver oil ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-777
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	140 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	719 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 g
SHARK LIVER OIL (UNII: 4B24275HEU) (SHARK LIVER OIL - UNII:4B24275HEU)	SHARK LIVER OIL	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
THYME OIL (UNII: 2UK410MY6B)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-777-88	1 in 1 CARTON
1		57 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/21/2011

Labeler - UNITED EXCHANGE CORP. (840130579)

Registrant - UNITED EXCHANGE CORP. (840130579)

Establishment
Name	Address	ID/FEI	Business Operations
TAI GUK PHARM. CO., LTD		631101656	manufacture