HEMORRHOID AND FISSURE DR. BUTLER- lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment

Hemorrhoid and Fissure by

Drug Labeling and Warnings

Hemorrhoid and Fissure 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 INGREDIENT

PURPOSE

Analgesic (pain relief), Vasoconstrictor

INDICATIONS & USAGE

Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning, itching). Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders.

WARNINGS

For external and/or intrarectal use only.

When using this product do not exceed recommended daily dosage unless directed by a doctor.

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 days, bleeding occurs. Introduction of applicator into the rectum causes additional pain.

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

KEEP OUT OF REACH OF CHILDREN

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

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.

INACTIVE INGREDIENT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMORRHOID AND FISSURE  DR. BUTLER
lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70942-023
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)
METHYLPARABEN (UNII: A2I8C7HI9T)
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)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
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: 70942-023-01	1 in 1 CARTON	08/28/2007
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 final	part346	08/28/2007

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(70942-023)