Warrior Rectal Care

Warrior Rectal Care
SPL v2
SPL
SPL Set ID fc10cbc3-fc1b-ae09-e053-6394a90ac8f3
Route
TOPICAL
Published
Effective Date 2023-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (0.25 g) Lidocaine (4 g)
Inactive Ingredients
Sunflower Oil Glyceryl Caprylate Glycerin Aloe Calendula Officinalis Flower Medium-chain Triglycerides Matricaria Chamomilla Leaf Caprylhydroxamic Acid Lysine Hydrochloride Mineral Oil Olive Oil Petrolatum Punica Granatum Root Bark Vitamin A Palmitate Stearic Acid .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-23

Description

Lidocaine 4%, Phenylephrine HCl 0.25%


Medication Information

Warnings and Precautions

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.

Indications and Usage

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Dosage and 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.

Description

Lidocaine 4%, Phenylephrine HCl 0.25%

Section 50565-1

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

Section 51727-6

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

Section 51945-4

Section 53414-9

Ask a health professional before use.

Section 55105-1

Analgesic (pain relief), Vasoconstrictor

Section 55106-9

Lidocaine 4%, Phenylephrine HCl 0.25%


Structured Label Content

Indications and Usage (34067-9)

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Analgesic (pain relief), Vasoconstrictor

Section 55106-9 (55106-9)

Lidocaine 4%, Phenylephrine HCl 0.25%


Advanced Ingredient Data


Raw Label Data

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