HEMORRHOIDAL - mineral oil,petrolatum,phenylephrine ointment 
Navarro Discount Pharmacies,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.

----------

Drug Facts

Active ingredients

Mineral oil 14%

Petrolatum 71.9%

Phenylephrine HCl 0.25%

Purpose

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

Other information

Store at 20o to 25oC (68o to 77oF)

Inactive ingredients

bees wax, butylated hydroxytoluene, cod liver oil, glycerin, lanolin, methylparaben, paraffin wax, propylparaben, purified water, sodium benzoate, squalane, thyme oil, tocopherol acelate

Package label

Vida Mia Hemorrhoidal Ointmentimage of carton label

HEMORRHOIDAL 
mineral oil,petrolatum,phenylephrine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59970-049
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL14 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM71.9 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
COD LIVER OIL (UNII: BBL281NWFG)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
THYME OIL (UNII: 2UK410MY6B)  
APIS MELLIFERA (UNII: 7S82P3R43Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59970-049-021 in 1 CARTON
157 g in 1 TUBE
2NDC:59970-049-011 in 1 CARTON
228 g in 1 TUBE
3NDC:59970-049-051 in 1 CARTON
319 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/13/2012
Labeler - Navarro Discount Pharmacies,LLC (094930963)

Revised: 8/2012
Document Id: 1dba961c-c76d-4a7f-8e2d-33f791537982
Set id: f55ed248-3b91-45ad-bb14-f66a89ab91b9
Version: 1
Effective Time: 20120813
 
Navarro Discount Pharmacies,LLC