DOCTOR BUTLER HEMORRHOID AND FISSURE ADVANCED FORMULA- glycerin 37.5%, lanolin 12.5%, lidocaine 4%, zinc oxide 5% ointment

Doctor Butler Hemorrhoid and Fissure by

Drug Labeling and Warnings

Doctor Butler Hemorrhoid and Fissure by is a Otc medication manufactured, distributed, or labeled by Beyond Health, PA, Derma Care Research Labs, Derrma Care Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Glycerin 37.5%, Lanolin 12.5%, Lidocaine 4%, Zinc Oxide 5%

PURPOSE

Anorectal (Hemorrhoidal)

Uses

• Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful from irritation and abrasion during bowl movement.
• For the temporary relief of pain, soreness, or burning
• Helps relieve the local or anorectal itching and discomfort associated with hemorrhoids

WARNINGS

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

When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor. Do not put this product into the rectum by using fingers or any mechanical device or applicator.

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.

PREGNANCY

If pregnant or breastfeeding, ask a health care professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

• Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying the ointment.
• Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
• Children under 12 years of age consult your pediatrician.

INACTIVE INGREDIENT

Aesculus Hippocastanum (Horse Chestnut) Extract

Argania Spinosa Kernel Oil

Calendula Officinalis Flower Extract

Camellia Sinensis Leaf Extract

Cananga Odorata Flower Oil

Canola Oil

Caprylic/Capric Triglyceride

Centella Asiatica Extract

Chamomilla Recutita (Matricaria) Flower Extract

Cocos Nucifera (Coconut) Oil

Curcuma Longa (Turmeric) Root Extract

Dunaliella Saline Extract

Euphorbia Cerifera (Candelilla) Wax

Helianthus Annuus (Sunflower) Seed Oil

Helianthus Annuus (Sunflower) Seed Wax

Hydrocortisone

Lavandula Angustifolia (Lavender) Oil

Linum Usitatissimum (Linseed) Seed Oil

Lysine HCl

Macadamia Ternifolia Seed Oil

Olea Europaea (Olive) Fruit Oil

Panax Ginseng Root Extract

Persea Gratissima (Avocado) Oil

Pogostemon Cablin Oil

Polyhydroxystearic Acid

Punica Granatum Fruit Extract

Ricinus Communis (Castor) Seed Oil

Rosa Canina Seed Oil

Sodium Hyaluronate

Tocopheryl Acetate

Triethoxycaprylylsilane

Viburnum Opulus Bark Extract

Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCTOR BUTLER HEMORRHOID AND FISSURE  ADVANCED FORMULA
glycerin 37.5%, lanolin 12.5%, lidocaine 4%, zinc oxide 5% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70942-131
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
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	12.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	37.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
VIBURNUM OPULUS WHOLE (UNII: DIO510WJ04)
WATER (UNII: 059QF0KO0R)
ASIAN GINSENG (UNII: CUQ3A77YXI)
AVOCADO OIL (UNII: 6VNO72PFC1)
POMEGRANATE (UNII: 56687D1Z4D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROCORTISONE (UNII: WI4X0X7BPJ)
CASTOR OIL (UNII: D5340Y2I9G)
ROSA CANINA SEED OIL (UNII: MHT97MG5P8)
MACADAMIA OIL (UNII: 515610SU8C)
OLIVE OIL (UNII: 6UYK2W1W1E)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
LINSEED OIL (UNII: 84XB4DV00W)
COCONUT OIL (UNII: Q9L0O73W7L)
CHAMOMILE (UNII: FGL3685T2X)
CANOLA OIL (UNII: 331KBJ17RK)
CANANGA OIL (UNII: 8YOY78GNNX)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
TURMERIC (UNII: 856YO1Z64F)
ARGAN OIL (UNII: 4V59G5UW9X)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CANDELILLA WAX (UNII: WL0328HX19)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70942-131-01	1 in 1 CARTON	05/02/2022
1		42.5 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	05/02/2022

Labeler - Beyond Health, PA (026781064)

Registrant - Derma Care Research Labs (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derrma Care Research Labs		116817470	manufacture(70942-131)