HEMORRHOID MASTER- lidocaine, phenylephrine hcl ointment

Hemorrhoid Master by

Drug Labeling and Warnings

Hemorrhoid Master by is a Otc medication manufactured, distributed, or labeled by Clinical Resolution Laboratory, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Lidocaine 4.00%

Phenylephrine HCl 0.25%

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.

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.

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.

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.

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

Purpose

Local Anesthetic

Vasoconstrictor

OTHER SAFETY INFORMATION

Other Information

■ Keep away from direct sunlight or heat.

■ Store at room temperature 15°-30°C (59°-86°F).

■ Keep out of reach of children.

■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.

■ Do not use this product if seal is broken or missing.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMORRHOID MASTER 
lidocaine, phenylephrine hcl ointment

Product 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)