DCH RAPID RELIEF HEMORRHOIDAL- lidocaine 5%, phenylephrine hydrochloride 0.25% spray

DCH Rapid Relief Hemorrhoidal by

Drug Labeling and Warnings

DCH Rapid Relief Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 5%, Phenylephrine HCl 0.25%,

PURPOSE

Topical Anesthetic, Vasoconstrictor

INDICATIONS & USAGE

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

WARNINGS

For external use only.

Flammable--do not use while smoking or near heat or flame.

When using this product avoid contact with eyes, contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F, do not exceed recommended daily dosage unless directed by a doctor, do not put this product in the rectum by using fingers or any mechanical device or applicator.

Ask a doctor before use if you have heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland, presently taking a prescription for high blood pressure or depression.

Stop use and ask a doctor if rectal bleeding occurs, the condition worsens or symptoms 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.

Ask a healthcare or professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

When practical, cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently pat dry. Spray the affected area, wash hands after applying. 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

Alcohol, Aloe Barbadensis Leaf Extract, Citric Acid, Disodium EDTA, Glycerin, Malic Acid, Menthol, Propyl Gallate, Propylene Glycol, Sodium Benzoate, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DCH RAPID RELIEF HEMORRHOIDAL 
lidocaine 5%, phenylephrine hydrochloride 0.25% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-263
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	0.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
MENTHOL (UNII: L7T10EIP3A)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MALIC ACID (UNII: 817L1N4CKP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-263-05	142 g in 1 CAN; Type 0: Not a Combination Product	02/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	02/24/2023

Labeler - Derma Care Research Labs (116817470)

Registrant - Derma Care Research Labs (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs		116817470	manufacture(72839-263)