MINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL- mineral oil, petrolatum, phenylephrine hcl ointment 
Axcentria Pharmaceuticals, 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

DRUG FACTS

ACTIVE INGREDIENTS

Mineral oil 14%

Petrolatum 71.9%

Phenylephrine HCl 0.25%

PURPOSES

Protectant

Protectant

Vasoconstrictor

USES

WARNINGS

For external and/or intrarectal use only

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or 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

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into the rectum causes additional pain

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

OTHER INFORMATION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, shark liver oil, thymus vulgaris (thyme) flower/leaf oil, tocopherols excipient, white wax

QUESTIONS?

To report adverse drug event call: (800) 616-2417

PRINCIPAL DISPLAY PANEL - 56.8 g Tube Carton

HEMORRHOIDAL
OINTMENT

TAMPER-EVIDENT: Do not use if printed "safety sealed" overwrap is broken or missing.

NET WT 2 OZ (56.8 g)

Principal Display Panel - 56.8 g Tube Carton
MINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL 
mineral oil, petrolatum, phenylephrine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49743-3047
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) PETROLATUM741 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CORN OIL (UNII: 8470G57WFM)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SHARK LIVER OIL (UNII: 4B24275HEU)  
THYME (UNII: CW657OBU4N)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WHITE WAX (UNII: 7G1J5DA97F)  
Product Characteristics
ColorYELLOW (smooth yellow ointment) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49743-3047-11 in 1 CARTON
156.8 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34606/28/2013
Labeler - Axcentria Pharmaceuticals, LLC (961871501)
Establishment
NameAddressID/FEIBusiness Operations
Axcentria Pharmaceuticals, LLC961871501ANALYSIS(49743-3047) , MANUFACTURE(49743-3047)

Revised: 6/2013
Document Id: d763cf0b-a67f-490c-852d-ce795fa6e62f
Set id: 9ea3b4ec-ad69-45fc-91d6-ffd9ee312591
Version: 1
Effective Time: 20130628
 
Axcentria Pharmaceuticals, LLC