DR BUTLERS HEMORRHOID AND FISSURE PF- lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment

Dr Butlers Hemorrhoid and Fissure PF by

Drug Labeling and Warnings

Dr Butlers Hemorrhoid and Fissure PF by is a Otc medication manufactured, distributed, or labeled by Beyond Health P.A., Derma Care Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine USP 4%

Phenylephrine HCl 0.25%

Purpose

Analgesic (pain relief)

Vasoconstrictor

Uses

• temporarily shrinks hemorrhoidal tissue
• for the temporary relief of pain, soreness, or burning
• helps relieve the local itching and discomfort associated with hemorrhoids

Warnings

For external use only including the skin of the anal canal.

When using this product

• do not exceed recommended dosage unless directed by a doctor
• when using finger cots or an applicator, apply externally or to 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
• 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 (7) days
• bleeding occurs
• an allergic reation develops
• the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

If pregnant or breast-feeding

as a health care professional before use.

Keep out of reach of children

if swallowed, seek medical help or contact a Poison Control Center right away.

Directions

• children under 12 years of age consult your pediatrician.
• adults: apply to affected area up to 4 times daily.
• cleanse the 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 apply externally to the skin of the anal canal only. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly

Other Information

• store at 15º-30º C (59º-86º F)

Inactive Ingedients

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, olea europaea (olive) fruit oil, panax ginseng root extract, petrolatum, porphyria umbilicalis extract, propylene glycol, punica granatum fruit extract, retinyl palmitate, sodium hyaluronate, stearic acid, tocopheryl acetate, triethoxycaprylysilane, water, zinc oxide

0.75oz / 21.3g tube

Carton of 12 0.07oz / 2g packets

INGREDIENTS AND APPEARANCE

DR BUTLERS HEMORRHOID AND FISSURE PF 
lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment

Product 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)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROCORTISONE (UNII: WI4X0X7BPJ)
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
MINERAL OIL (UNII: T5L8T28FGP)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
OLIVE OIL (UNII: 6UYK2W1W1E)
ASIAN GINSENG (UNII: CUQ3A77YXI)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
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	NDC: 70942-357-00	28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70942-357-75	1 in 1 CARTON	07/22/2025
2	NDC: 70942-357-07	21.3 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 70942-357-12	12 in 1 CARTON	02/20/2023
3	NDC: 70942-357-06	2 g in 1 PACKET; 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)