HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine ointment 
Geritrex LLC

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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Hemorrhoidal Ointment


Active Ingredient                    Purpose
Mineral Oil - 14%                   Protectant
Petrolatum - 71.9%              Protectant
Phenylephrine - 0.25%          Astringent

Uses:

Warnings:

For external and/or intrarectal use only

Ask a doctor before use if you have

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

When using this product:

Do not exceed the recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if:

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

KEEP OUT OF REACH OF CHILDREN

If swallowed get medical help or contact a poison control center right away.

Directions:


For Intrarectal use

Other Information:

Store at room temperature but not over 80­° F
Lot No. & Exp Date: See tube

Inactive Ingredients:

Beeswax, benzoic acid, BHA, corn oil, glycern, lanolin alcohol, methyparaben, paraffin, propylparaben, shark liver oil, thyme, tocopherol, water.

image description

HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-044
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL7.98 g  in 57 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM40.983 g  in 57 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.1425 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CORN OIL (UNII: 8470G57WFM)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SHARK LIVER OIL (UNII: 4B24275HEU)  
THYME (UNII: CW657OBU4N)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-044-0257 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product07/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/31/2015
Labeler - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
Geritrex LLC112796248manufacture(54162-044)

Revised: 7/2015
Document Id: 59f83f77-c625-4bbc-bca0-2595fd3e2730
Set id: 6445e94b-8b48-489a-98c8-cae6b0ac33c7
Version: 1
Effective Time: 20150731
 
Geritrex LLC