BUDPAK HEMORRHOID ANESTHETIC- mineral oil, petrolatum and phenylephrine hydrochloride ointment 
Budpak 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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Active Ingredients

Mineral Oil 14%

Petrolatum 71.9%

Phenylephrine HCL 0.25%

Purpose

Protectant

Protectant

Vasoconstrictor

Uses

  • For the temporary relief of local anorectal burning and discomfort associated with hemmorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles.

Warnings

For external use only

  • Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear-up and occur again within a few days.
  • Do not exceed the recommended daily dosage unless directed by a doctor.

  • In case of bleeding, consult a doctor promptly.

  • Certain persons can develop allergic reactions to ingredients in this product.

  • If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

  • If you are pregnant, do not use this product without first consulting a doctor.

Keep out of reach of children.

If ingested seek medical attention immediately or contact a Poison Control Center right away.

Directions

  • Cleanse the affected area with mild soap and warm water, rinse thoroughly.
  • Dry by patting or blotting with toilet tissue or soft cloth before applying this product.
  • Cover the entire affected area with a thin layer 1 to 3 times daily.
  • Children under 12 years of age need to consult a doctor before using this product.

Other Information

  • Store at room temperature 20ºC to 25ºC (68ºF to 77ºF)
  • Lot No. & Exp. Date: see crimp of tube.

Inactive Ingredients

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, mineral oil, paraffin, propylparaben, shark liver oil, thyme oil, tocopherol acetate, yellow wax, purified water.

PRINCIPAL DISPLAY PANEL

Budpak Hemorrhoid Anesthetic Ointment

Mineral Oil 14%

Petrolatum 71.9%

Phenylephrine HCL 0.25%

NET WT 1 OZ (28 g)

image of package label

BUDPAK HEMORRHOID ANESTHETIC 
mineral oil, petrolatum, phenylephrine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-026
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL0.14 g  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM0.719 g  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE0.0025 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
CORN OIL 
GLYCERIN 
LANOLIN 
LANOLIN ALCOHOLS 
METHYLPARABEN 
PARAFFIN 
PROPYLPARABEN 
SHARK LIVER OIL 
THYME OIL 
.ALPHA.-TOCOPHEROL ACETATE 
YELLOW WAX 
WATER 
Packaging
#Item CodePackage Description
1NDC:27293-026-011 in 1 BOX
1NDC:27293-026-2828 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34606/10/2013
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-026)

Revised: 06/2013
 
Budpak Inc.