Norms Hemorrhoidal Cream

Norms Hemorrhoidal Cream
SPL v1
SPL
SPL Set ID 3bdf8c74-3db6-1805-e063-6394a90aaba0
Route
TOPICAL
Published
Effective Date 2025-08-08
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 2025-08-08

Description

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


Medication Information

Warnings and Precautions

For external use only.

When using this product 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.

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

Indications and Usage

Helps relieve the pain, itching, and burning associated with hemorrhoids. Temporarily shrinks hemorrhoidal tissue. Temporarily provides a coating for relief of anorectal discomforts. Temporarily protects irritated areas and inflamed perineal skin.

Dosage and Administration

Adults: apply up to 3 times daily or after each bowl movement. When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before each application of this product. To use finger gots: roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Children under 12 years of age: consult your pediatrician.

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)

Helps relieve the pain, itching, and burning associated with hemorrhoids. Temporarily shrinks hemorrhoidal tissue. Temporarily provides a coating for relief of anorectal discomforts. Temporarily protects irritated areas and inflamed perineal skin.

Dosage and Administration (34068-7)

Adults: apply up to 3 times daily or after each bowl movement. When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before each application of this product. To use finger gots: roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Children under 12 years of age: consult your pediatrician.

Warnings and Precautions (34071-1)

For external use only.

When using this product 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.

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

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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