WARRIOR RECTAL CARE- lidocaine 4%, phenylephrine hydrochloride 0.25% ointment

Warrior Rectal Care by

Drug Labeling and Warnings

Warrior Rectal Care 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 4%, Phenylephrine HCl 0.25%

PURPOSE

Analgesic (pain relief), Vasoconstrictor

INDICATIONS & USAGE

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 do not exceed recommended daily dosage unless directed by a doctor.

Do not use this product if you have 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.

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 4 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.

FOR INTRARECTAL USE: attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Thoroughly cleanse applicator after each use and replace cover.

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Extract, Calendula Officinalis Flower Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Lysine HCl, Mineral Oil,
Olea Europaea (Olive) Fruit Oil, Petrolatum, Punica Granatum Extract, Retinyl Palmitate, Stearic Acid, Tocopheryl Acetate, Water

PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WARRIOR RECTAL CARE 
lidocaine 4%, phenylephrine hydrochloride 0.25% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	0.25 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
MINERAL OIL (UNII: T5L8T28FGP)
MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0)
OLIVE OIL (UNII: 6UYK2W1W1E)
PETROLATUM (UNII: 4T6H12BN9U)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-071-01	1 in 1 CARTON	01/23/2023
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	01/23/2023

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(72839-071)