Label: DR BUTLERS HEMORRHOID AND FISSURE PF- lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment
- NDC Code(s): 70942-357-01
- Packager: Beyond Health P.A.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
For external use only including the skin of the anal canal.
When using this product do not exceed recommended daily dosage unless directed by a doctor, when using finger cots or an applicator, apply externally or the skin of the anal canal only. Do not put this product into the rectum.
Ask a doctor before use if you have allergies to any of the components of this product, difficulty in urination due to enlargement of the prostate gland, diabetes, heart disease, high blood pressure, thyroid disease, or presently taking a prescription for high blood pressure or depression.
Stop use and ask a doctor if condition worsens or does not improve within seven days, bleeding occurs, an allergic reaction develops, the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Children under 12 years of age consult your pediatrician.
Adults: apply to affected area up to 3 times daily.
Clean affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use.
To use dispensing cap, attach it to tube, lubricate well then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly.
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INACTIVE INGREDIENT
Aesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, ascorbic acid, calendula officinalis flower extract, caprylhydroxamic acid, caprylic/capric triglyceride, centella asiatica extract, chamomile recutita (matricaria) flower extract, cholecalciferol, glycerin, glyceryl caprylate, helianthus annuus (sunflower) seed oil, hydrocortisone, laminaria digitata (algae) extract, lysine HCl, mineral oil, octyldodecanol, olea europaea (olive) fruit oil, panax ginseng root extract, PEG-8 dimehticone, petrolatum, porphyria umbilicalis extract, propylene glycol, punica granatum fruit extract, pyridoxine HCl, retinyl palmitate, silica, sodium hyaluronate, sodium propoxyhydroxypropyl thiosulfate silica, stearic acid, tocopheryl acetate, triethoxycaprylysilance, water, zea mays (corn) oil, zinc oxide
- PREGNANCY OR BREAST FEEDING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR BUTLERS HEMORRHOID AND FISSURE PF
lidocaine 4.00, phenylephrine hydrochloride 0.25 ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70942-357 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 0.25 g in 100 g Inactive Ingredients Ingredient Name Strength HORSE CHESTNUT (UNII: 3C18L6RJAZ) ALOE (UNII: V5VD430YW9) ASCORBIC ACID (UNII: PQ6CK8PD0R) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) TRICAPRYLIN (UNII: 6P92858988) CENTELLA ASIATICA (UNII: 7M867G6T1U) CHOLECALCIFEROL (UNII: 1C6V77QF41) SUNFLOWER OIL (UNII: 3W1JG795YI) HYDROCORTISONE (UNII: WI4X0X7BPJ) LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM) MINERAL OIL (UNII: T5L8T28FGP) OCTYLDODECANOL (UNII: 461N1O614Y) OLIVE OIL (UNII: 6UYK2W1W1E) ASIAN GINSENG (UNII: CUQ3A77YXI) PEG-8 DIMETHICONE (UNII: GIA7T764OD) PETROLATUM (UNII: 4T6H12BN9U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) CORN OIL (UNII: 8470G57WFM) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70942-357-01 1 in 1 CARTON 02/20/2023 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 02/20/2023 Labeler - Beyond Health P.A. (026781064) Registrant - Derma Care Research Labs (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs 116817470 manufacture(70942-357)