WESTERN FAMILY HEMORRHOIDAL  - mineral oil 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 74.9%.........................................................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 20° to 25°C (68° to 77°F)

Inactive ingredients glycerin, lanolin, methylparaben, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax

Proudly Distributed by Western Family Foods, Inc.

P.O. Box 4057, Portland, OR 97208 U.S.A.

Made in Korea

image of carton label

WESTERN FAMILY HEMORRHOIDAL  
mineral oil ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM749 mg  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
THYME OIL (UNII: 2UK410MY6B)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-035-571 in 1 CARTON
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34606/30/2013
Labeler - Western Family Food, Inc. (192166072)

Revised: 6/2013
Document Id: 7823fa33-13ad-492e-842e-af3f5ca88cd9
Set id: 9ea5e0ce-2bce-4a27-9701-046913a21b09
Version: 1
Effective Time: 20130630
 
Western Family Food, Inc.