WESTERN FAMILY HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hcl ointment

WESTERN FAMILY HEMORRHOIDAL by

Drug Labeling and Warnings

WESTERN FAMILY HEMORRHOIDAL by is a Otc medication manufactured, distributed, or labeled by WESTERN FAMILY FOOD, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                              Purpose

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

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

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

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

Proudly Distributed by Western Family Foods, Inc.

P.O. Box 4057, Portland, OR 97208 USA

www.westernfamily.com

Made in Korea

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

WESTERN FAMILY HEMORRHOIDAL  
mineral oil, petrolatum, phenylephrine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55312-034
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

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55312-034-02	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	07/31/2012

Labeler - WESTERN FAMILY FOOD, INC. (192166072)