Dch Rapid Relief Hemorrhoidal Spray

Dch Rapid Relief Hemorrhoidal Spray
SPL v2
SPL
SPL Set ID 00eef84c-a72e-3343-e063-6294a90aa4d8
Route
TOPICAL
Published
Effective Date 2023-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g) Phenylephrine (0.25 g)
Inactive Ingredients
Aloe Menthol Alcohol Propylene Glycol Propyl Gallate Sodium Benzoate Edetate Disodium Citric Acid Monohydrate Water Glycerin Malic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-24

Description

Lidocaine 5%, Phenylephrine HCl 0.25%,


Medication Information

Warnings and Precautions

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.

Indications and Usage

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

Dosage and 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.

Description

Lidocaine 5%, Phenylephrine HCl 0.25%,

Section 50565-1

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

Section 51727-6

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

Section 51945-4

Section 53414-9

Ask a healthcare or professional before use.

Section 55105-1

Topical Anesthetic, Vasoconstrictor

Section 55106-9

Lidocaine 5%, Phenylephrine HCl 0.25%,


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Ask a healthcare or professional before use.

Section 55105-1 (55105-1)

Topical Anesthetic, Vasoconstrictor

Section 55106-9 (55106-9)

Lidocaine 5%, Phenylephrine HCl 0.25%,


Advanced Ingredient Data


Raw Label Data

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