BUDPAK HEMORRHOID ANESTHETIC- mineral oil, petrolatum, phenylephrine hcl ointment

Budpak Hemorrhoid Anesthetic by

Drug Labeling and Warnings

Budpak Hemorrhoid Anesthetic by is a Otc medication manufactured, distributed, or labeled by Budpak Inc. , Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCL 0.25%

PURPOSE

Purpose

Protectant

Protectant

Vasoconstrictor

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only

STOP USE

• 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

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

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.

SPL UNCLASSIFIED SECTION

Other Information

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

INACTIVE INGREDIENT

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.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Budpak Hemorrhoid Anesthetic Ointment

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCL 0.25%

NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUDPAK HEMORRHOID ANESTHETIC 
mineral oil, petrolatum, phenylephrine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	0.14 g  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	0.749 g  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.0025 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)
SHARK LIVER OIL (UNII: 4B24275HEU)
THYME OIL (UNII: 2UK410MY6B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
YELLOW WAX (UNII: 2ZA36H0S2V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-026-01	1 in 1 BOX
1	NDC: 27293-026-28	28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	06/10/2013

Labeler - Budpak Inc. (183224849)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(27293-026)