Dch Hemorrhoidal Pain Relief Cream

Dch Hemorrhoidal Pain Relief Cream
SPL v2
SPL
SPL Set ID 0050701f-4393-3f01-e063-6394a90a4e0e
Route
TOPICAL
Published
Effective Date 2023-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g) Petrolatum (15 g) Glycerin (14.4 g) Phenylephrine (0.25 g)
Inactive Ingredients
Phenoxyethanol .alpha.-tocopherol Acetate Xanthan Gum Cetyl Alcohol Citric Acid Monohydrate Edetate Disodium Panthenol Butylated Hydroxyanisole Aloe Vera Leaf Sorbitan Olivate Steareth-21 Water Ethylhexylglycerin Glyceryl Monostearate Propyl Gallate Propylene Glycol Carboxymethylcellulose Sodium Stearyl Alcohol Tocopherol Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-12

Description

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%


Medication Information

Warnings and Precautions

For external use only.

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

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

When using this product: avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if: rectal bleeding occurs, condition worsens or does not improve within seven (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, symptoms clear up and return within a few days.

Indications and Usage

For the temporary relief of pain, soreness, and burning. Helps relieve the local itching and discomfort associated with hemorrhoids. Temporarily shrinks hemorrhoidal tissue. Temporarily provides a coating for the relief of anorectal discomforts. Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.

Dosage and Administration

Adults: when practical, cleanse area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 4 times a day. Children under 12 years of age: consult a doctor.

Description

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, 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, BHA, cellulose gum, cetyl alcohol, citric acid, disodium EDTA, ethylhexylglycerin, glyceryl stearate, mineral oil, panthenol, Phenoxyethanol, propyl gallate, propylene glycol, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, xanthan gum.

Section 51945-4

Section 53414-9

Ask a health care professional before use.

Section 55105-1

Anorectal/Hemorrhoidal

Section 55106-9

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of pain, soreness, and burning. Helps relieve the local itching and discomfort associated with hemorrhoids. Temporarily shrinks hemorrhoidal tissue. Temporarily provides a coating for the relief of anorectal discomforts. Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.

Dosage and Administration (34068-7)

Adults: when practical, cleanse area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 4 times a day. Children under 12 years of age: consult a doctor.

Warnings and Precautions (34071-1)

For external use only.

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

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

When using this product: avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if: rectal bleeding occurs, condition worsens or does not improve within seven (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, symptoms clear up and return within a few days.

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, BHA, cellulose gum, cetyl alcohol, citric acid, disodium EDTA, ethylhexylglycerin, glyceryl stearate, mineral oil, panthenol, Phenoxyethanol, propyl gallate, propylene glycol, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, xanthan gum.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Ask a health care professional before use.

Section 55105-1 (55105-1)

Anorectal/Hemorrhoidal

Section 55106-9 (55106-9)

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%


Advanced Ingredient Data


Raw Label Data

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