Cvs Health Hemorrhoidal Cream, 28g

Cvs Health Hemorrhoidal Cream, 28g
SPL v4
SPL
SPL Set ID cb448d78-553c-4e65-80c5-d4b31d7b3661
Route
TOPICAL
Published
Effective Date 2019-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (14.4 g) Phenylephrine (0.25 g) Pramoxine (1 g) Petrolatum (15 g)
Inactive Ingredients
Aloe Vera Leaf Carboxymethylcellulose Sodium Cetyl Alcohol Glyceryl Monostearate Methylparaben Paraffin Propylene Glycol Propylparaben Stearic Acid Polysorbate 80 Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-02-12

Description

Active ingredients Glycerin 14.4% Phenylephrine HCl 0.25% Pramoxine HCl 1% White petrolatum 15%


Medication Information

Warnings and Precautions

Warnings

. For external use only

•do not put this product into the rectum by When using this product

using fingers or any mechanical device or applicator •do not exceed

recommended daily dosage unless directed by a doctor

Ask a doctor before use if you have

•heart disease •high blood pressure •thyroid disease •diabetes

•trouble urinating due to an enlarged prostate gland

presently taking a Ask a doctor or pharmacist before use if you are

prescription drug for high blood pressure or depsression

Stop use and ask a doctor if

•bleeding occurs •condition worsens or does not improve within 7 days

•if the symptoms being treated do not subside or if redness, irritation,

swelling, pain or other symptoms develop or increase. Some people can

develop allergic reactions to ingredients in this product.

, ask a health professional before use. If pregnant or breast-feeding

Indications and Usage

•for temporary relief of pain, soreness and burning •helps relieve Uses 

the local itching and discomfort associated ith hemorrhoids

•temporarily provides a coating for f of anorectal discomforts

•temporarily protects the inflamed irritated anorectal surface to help make

bowel movements less painful  •temporarily shrinks hemorrhoidal tissue

Dosage and Administration

Adults: Directions

•when practical, cleanse the affected area with mild soap and water and rinse thoroughly.

Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.

•apply externally to the affected area up to 4 times daily, especially at night or in the

morning or after each bowel movement.

Children under 12 years of age: consult a doctor.

Description

Active ingredients Glycerin 14.4% Phenylephrine HCl 0.25% Pramoxine HCl 1% White petrolatum 15%

Section 44425-7

store at room temperature 68° - 77° F (20° -  25° C) Other information

Section 50565-1

. If swallowed, get medical help or contact Keep out of reach of children

a Poison Control Center right away.

Section 51727-6

aloe barbadensis leaf extract, carboxymethyllcellulose Inactive ingredients

sodium, cetyl alcohol, glyceryl monostearate, methylparaben, paraffin, propylene

glycol, propylparaben, stearic acid, tween 80, water, xanthan gum

Section 51945-4

Section 53413-1

1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?

Section 55105-1

Purpose

Glycerin 14.4% ...........................Protectant

Phenylephrine HCl 0.25% .............Vasoconstrictor

Pramoxine HCl 1%........................Local anesthetic

White petrolatum 15%..................Protectant

Section 55106-9

Active ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%


Structured Label Content

Indications and Usage (34067-9)

•for temporary relief of pain, soreness and burning •helps relieve Uses 

the local itching and discomfort associated ith hemorrhoids

•temporarily provides a coating for f of anorectal discomforts

•temporarily protects the inflamed irritated anorectal surface to help make

bowel movements less painful  •temporarily shrinks hemorrhoidal tissue

Dosage and Administration (34068-7)

Adults: Directions

•when practical, cleanse the affected area with mild soap and water and rinse thoroughly.

Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.

•apply externally to the affected area up to 4 times daily, especially at night or in the

morning or after each bowel movement.

Children under 12 years of age: consult a doctor.

Warnings and Precautions (34071-1)

Warnings

. For external use only

•do not put this product into the rectum by When using this product

using fingers or any mechanical device or applicator •do not exceed

recommended daily dosage unless directed by a doctor

Ask a doctor before use if you have

•heart disease •high blood pressure •thyroid disease •diabetes

•trouble urinating due to an enlarged prostate gland

presently taking a Ask a doctor or pharmacist before use if you are

prescription drug for high blood pressure or depsression

Stop use and ask a doctor if

•bleeding occurs •condition worsens or does not improve within 7 days

•if the symptoms being treated do not subside or if redness, irritation,

swelling, pain or other symptoms develop or increase. Some people can

develop allergic reactions to ingredients in this product.

, ask a health professional before use. If pregnant or breast-feeding

Section 44425-7 (44425-7)

store at room temperature 68° - 77° F (20° -  25° C) Other information

Section 50565-1 (50565-1)

. If swallowed, get medical help or contact Keep out of reach of children

a Poison Control Center right away.

Section 51727-6 (51727-6)

aloe barbadensis leaf extract, carboxymethyllcellulose Inactive ingredients

sodium, cetyl alcohol, glyceryl monostearate, methylparaben, paraffin, propylene

glycol, propylparaben, stearic acid, tween 80, water, xanthan gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?

Section 55105-1 (55105-1)

Purpose

Glycerin 14.4% ...........................Protectant

Phenylephrine HCl 0.25% .............Vasoconstrictor

Pramoxine HCl 1%........................Local anesthetic

White petrolatum 15%..................Protectant

Section 55106-9 (55106-9)

Active ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%


Advanced Ingredient Data


Raw Label Data

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