FREDS HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hydrochloride cream 
Freds, 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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Fred's Hemorrhoidal Ointment 2oz w/applicator NBE Preparation H

Active Ingredients                                                   Purpose

Mineral Oil 14%................................................... Protectant

Petrolatum 74.9%................................................ Protectant

Phenylephrine Hydrochloride 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

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, proplyparaben, steryl alcohol, thyme oil, tocopherol acetate, water, white wax

DISTRIBUTED BY:

FRED'S, INC.

4300 NEW GETWELL RD.

MEMPHIS, TN 38118 USA

image description

FREDS HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-336
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) PETROLATUM749 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 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:55315-336-571 in 1 BOX10/06/2016
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/03/2014
Labeler - Freds, Inc (005866116)

Revised: 12/2017
Document Id: 602d79a7-07a6-31a3-e053-2a91aa0a0785
Set id: c940fab1-b842-4ba7-af38-87faa33346c4
Version: 3
Effective Time: 20171212
 
Freds, Inc