DOCTOR BUTLERS HEMORRHOID AND FISSURE EXTERNAL PAIN FORMULA- lidocaine 5% ointment

Doctor Butlers Hemorrhoid and Fissure by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 5.0%

PURPOSE

Local Anesthetic

Uses

Helps relieve the local itching and discomfort associated with anorectal disorders or inflammation.

WARNINGS

For external use only.

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 rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, or symptoms clear up and return within a few days.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a 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

• When practical, cleanse the area with mild soap and warm water. Rinse thoroughly and gently pat dry.
• Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
• Children under 12 years of age: consult a doctor.

INACTIVE INGREDIENT

Aesculus Hippocastanum (Horse Chestnut) Extract, Benzyl Alcohol, Calendula Officinalis Flower Extract, Calendula Officinalis flower Extract, Carbomer, Carya Ovata Bark Extract, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cholesterol, Curcuma Longa (Turmeric) Root Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Helichrysum Italicum Extract, Hydrogenated Lecithin, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Olea Europaea (Olive) Leaf Extract, Panax Ginseng Root Extract, Polysorbate 80, Propylene Glycol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Hyaluronate, Tocopheryl Acetate, Triethanolamine, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCTOR BUTLERS HEMORRHOID AND FISSURE  EXTERNAL PAIN FORMULA
lidocaine 5% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70942-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
TURMERIC (UNII: 856YO1Z64F)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
CARYA OVATA BARK (UNII: X765CF609L)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER 940 (UNII: 4Q93RCW27E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
ASIAN GINSENG (UNII: CUQ3A77YXI)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
ROSEMARY (UNII: IJ67X351P9)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70942-121-01	28 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2022
2	NDC: 70942-121-11	28 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/01/2022

Labeler - Beyond Health, P.A. (026781064)

Registrant - Derma Care Research Labs (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derrma Care Research Labs		116817470	manufacture(70942-121)