WESTERN FAMILY HEMORRHOIDAL  - mineral oil, petrolatum, phenylephrine hcl ointment 
WESTERN FAMILY FOOD, INC.

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.

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Drug Facts

Active ingredients                                                              Purpose

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

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

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

Uses

Warnings

For external and/or intrarectal use only

Ask a doctor before use if you have

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

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

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

Proudly Distributed by Western Family Foods, Inc.

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

www.westernfamily.com

Made in Korea

image of carton labelEnter section text here

WESTERN FAMILY HEMORRHOIDAL  
mineral oil, petrolatum, phenylephrine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM719 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-034-021 in 1 CARTON
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/31/2012
Labeler - WESTERN FAMILY FOOD, INC. (192166072)

Revised: 7/2012
Document Id: 843b7897-d103-43eb-bcb1-2a3841c1ac8a
Set id: 75223cc8-d565-43ca-b176-3d58bdc35ed8
Version: 2
Effective Time: 20120731
 
WESTERN FAMILY FOOD, INC.