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

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

WARNINGS

For external and/or intrarectal use only.

When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor. 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.

Ask a doctor before use if you have allergies to any of the components of this product.

Stop use and ask a doctor if condition worsens or does not improve within seven days or bleeding occurs.

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

• Children under 12 years of age consult your pediatrician.
• Adults: Apply to the affected area up to 3 times daily.
• Clean affected area with mild soap and warm water, rinse thoroughly, and gently dry (patting or blotting) with tissue or soft cloth before use.
• The ointment can be applied using a gloved finger or finger cot.
• To use finger cots: roll one finger cot over finger. Gently squeeze ointment onto finger cot. Smooth a layer of the ointment over affected area or into anus.

INACTIVE INGREDIENT

Aesculus Hippocastanum (Horse Chestnut) Extract

Algae Extract

Argania Spinosa Kernel Oil

Benzyl Alcohol

Calendula Officinalis Flower Extract

Camellia Sinensis Leaf Extract

Cananga Odorata Flower Oil

Canola Oil

Caprylhydroxamic Acid

Caprylic/Capric Triglyceride

Centella Asiatica Extract

Chamomilla Recutita (Matricaria) Flower Extract

Cocos Nucifera (Coconut) Oil

Curcuma Longa (Turmeric) Root Extract

Euphorbia Cerifera (Candelilla) Wax

Glyceryl Caprylate

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: 70942-517
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	37.5 g  in 100 g
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

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
VIBURNUM OPULUS WHOLE (UNII: DIO510WJ04)
WATER (UNII: 059QF0KO0R)
ASIAN GINSENG (UNII: CUQ3A77YXI)
AVOCADO OIL (UNII: 6VNO72PFC1)
POMEGRANATE (UNII: 56687D1Z4D)
CANDELILLA WAX (UNII: WL0328HX19)
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)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70942-517-01	1 in 1 CARTON	09/20/2021
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 final	part346	09/20/2021

Labeler - Beyond Health, PA (026781064)

Registrant - Derma Care Research Labs (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derrma Care Research Labs		116817470	manufacture(70942-517)