LIDOCAINE HEMORRHOID- lidocaine hcl, phenylephrine hcl, witch hazel spray

Lidocaine Hemorrhoid by

Drug Labeling and Warnings

Lidocaine Hemorrhoid by is a Otc medication manufactured, distributed, or labeled by Walgreens Co, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine HCl 5%, Phenylephrine HCl 0.25%, Witch Hazel 50%

PURPOSE

Anorectal; anesthetic, vasoconstrictor, astringent

INDICATIONS & USAGE

• Temporarily shrinks hemorrhoidal tissue
• Temporarily reduces the swelling and irritation associated with hemorrhoids and other anorectal disorders
• aids in protecting irritated anorectal areas

INDICATIONS & USAGE

Temporarily shrinks hemorrhoidal tissue. Temporarily reduces the swelling and irritation associated with hemorrhoids and other anorectal disorders. Aids in protecting irritated anorectal areas.

WARNINGS

For external use only.

Flammable. Do not use while smoking or near heat or flame.

When using this product

• keep away from children
• avoid spraying in eyes
• contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F
• do not exceed the recommended daily dosage unless directed by a doctor
• do not put this product into the rectum by using fingers or any mechanical device or applicator
• certain persons can develop allergic reactions to ingredients in this product. If the symptoms 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 or pharmacist before use if you have

• heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland
• are presently taking a prescription drug for high blood pressure or depression

Stop use and ask a doctor if

• bleeding occurs
• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• needed for longer than 1 week

PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

DOSAGE & ADMINISTRATION

• Adults: when practical, cleanse the affected are with an appropriate cleansing wipe.
• Spray rectal area until thoroughly moist. Wipe off excess with tissue.
• Gently dry by patting or blotting with a tissue or a soft cloth.
• Apply 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 a doctor.

INACTIVE INGREDIENT

alcohol, aloe barbadensis leaf extract, anthemis nobilis flower extract, benzophenone-4, benzyl alcohol, centella asiatica extract,disodium EDTA, epilobium angustifolium extract, ethylhexylglycerin, glycerin, hydroxyethylcellulose, polysorbte 40, propylene glycol, sodium citrate, tocopherol, tocopheryl acetate, water.

QUESTIONS

1-800-925-4733

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE HEMORRHOID 
lidocaine hcl, phenylephrine hcl, witch hazel spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1657
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	50 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
POLYSORBATE 40 (UNII: STI11B5A2X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
SULISOBENZONE (UNII: 1W6L629B4K)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALCOHOL (UNII: 3K9958V90M)
EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1657-03	85 g in 1 CAN; Type 0: Not a Combination Product	02/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	02/05/2024

Labeler - Walgreens Co (008965063)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(0363-1657)