NDC | 27293-026-01, 27293-026-28 |
Set ID | 8cb751f8-9a7d-4f2b-94b8-7f40ab2c23a6 |
Category | HUMAN OTC DRUG LABEL |
Packager | Budpak Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART346 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
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.
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Certain persons can develop allergic reactions to ingredients in this product.
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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
-
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
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BUDPAK HEMORRHOID ANESTHETIC
mineral oil, petrolatum, phenylephrine hcl ointmentProduct 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)