Label: HEMORRHOIDALCREAMPRO- phenylephrine hcl, petrolatum, mineral oil cream
- NDC Code(s): 77338-410-55
- Packager: ASTONEA LABS PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 25, 2024
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external 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
- do not put into the rectum by using fingers or any mechanical device or applicator
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DOSAGE & ADMINISTRATION
Directions
- Adults: when possible, clean affected area with mild soap or warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use
- To use applicator, attach it to the tube, lubricate well, then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse applicator after use with mild soap and warm water and rinse thoroughly
- Apply externally to the affected area up to 4 times daily, especially at night, when waking up and after each bowel movement
- Children under 12 years of age: ask a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEMORRHOIDALCREAMPRO
phenylephrine hcl, petrolatum, mineral oil creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77338-410 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 14 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 74.9 g in 100 g Inactive Ingredients Ingredient Name Strength POLYOXYL 100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WHITE WAX (UNII: 7G1J5DA97F) THYMUS VULGARIS LEAF (UNII: GRX3499643) BENZOIC ACID (UNII: 8SKN0B0MIM) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CORN OIL (UNII: 8470G57WFM) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77338-410-55 56.6 g in 1 TUBE; Type 0: Not a Combination Product 10/05/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 10/05/2022 Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)