Label: HEMORRHOID MASTER- lidocaine, phenylephrine hcl ointment
- NDC Code(s): 63742-045-01
- Packager: Clinical Resolution Laboratory, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 4, 2025
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- ACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
Directions
■ Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.
■ For External Use: Apply externally to the affected area up to 4 times daily.
■ For Intrarectal use: Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Apply to the affected area up to 4 times daily.
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WARNINGS
Warnings:For external and/ or intrarectal use only.
■ If condition worsens or does not improve within 7 days, consult a doctor.
■ 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.
■ Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
■ Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
■ Do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.
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INDICATIONS & USAGE
Uses
■ For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation.
■ For the temporary relief of pain, burning and soreness.
■ Temporarily shrinks hemorrhoidal tissue.
■ Temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders.
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KEEP OUT OF REACH OF CHILDREN
■ Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.
■ For External Use: Apply externally to the affected area up to 4 times daily.
■ For Intrarectal use: Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Apply to the affected area up to 4 times daily.
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INACTIVE INGREDIENT
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Cholecalciferol, Cholesterol, Diisopropyl Sebacate, Dimethyl Isosorbide, Dodecane, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydrocortisone, Isododecane, Isopropyl Myristate, Lecithin, Mentha Piperita (Peppermint) Oil, Microcrystalline Wax, Mineral Oil, Octyldodecanol, Panax Ginseng Root Extract, PEG-8 Dimethicone, Petrolatum, Phenoxyethanol, Phospholipids, Polyethylene, Propylene Glycol, Punica Granatum Extract, Pyridoxine HCl, Retinyl Palmitate, Silica, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water, Zea Mays (Corn) Oil, Zinc Oxide
- PURPOSE
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEMORRHOID MASTER
lidocaine, phenylephrine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63742-045 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 mg in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) PETROLATUM (UNII: 4T6H12BN9U) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MINERAL OIL (UNII: T5L8T28FGP) ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB) ASCORBIC ACID (UNII: PQ6CK8PD0R) HYDROCORTISONE (UNII: WI4X0X7BPJ) WATER (UNII: 059QF0KO0R) ZEA MAYS (CORN) OIL (UNII: 8470G57WFM) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH) PANAX GINSENG ROOT (UNII: CUQ3A77YXI) SILICA (UNII: ETJ7Z6XBU4) CHOLECALCIFEROL, (5E)- (UNII: W28SLM7V6D) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) DODECANE (UNII: 11A386X1QH) ETHOXYDIGLYCOL (UNII: A1A1I8X02B) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PEG-8 DIMETHICONE (UNII: GIA7T764OD) PHENOXYETHANOL (UNII: HIE492ZZ3T) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) POLYETHYLENE (UNII: UG00KM4WR7) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) RETINYL PALMITATE (UNII: 1D1K0N0VVC) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ZINC OXIDE (UNII: SOI2LOH54Z) ISODODECANE (UNII: A8289P68Y2) ASCORBYL PALMITATE (UNII: QN83US2B0N) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OCTYLDODECANOL (UNII: 461N1O614Y) POMEGRANATE (UNII: 56687D1Z4D) PYRIDOXINE HCL (UNII: 68Y4CF58BV) SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHAMOMILE (UNII: FGL3685T2X) CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL (UNII: 65UEH262IS) CETEARYL ALCOHOL (UNII: 2DMT128M1S) CHOLESTEROL (UNII: 97C5T2UQ7J) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) Product Characteristics Color white (Yellowish White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63742-045-01 45 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 11/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 11/01/2019 Labeler - Clinical Resolution Laboratory, Inc. (825047942) Registrant - Clinical Resolution Laboratory, Inc. (825047942) Establishment Name Address ID/FEI Business Operations Clinical Resolution Laboratory, Inc. 825047942 manufacture(63742-045)

