Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d
Route
TOPICAL
Published
Effective Date 2013-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (0.25 g) Mineral Oil (14 g) Petrolatum (74.9 g)
Inactive Ingredients
Yellow Wax Benzoic Acid Cetyl Alcohol Glycerin Laureth-23 Methylparaben Propylparaben Stearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-03-01

Description

beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23, methylparaben, propylparaben, stearyl alcohol Inactive Ingredients


Medication Information

Indications and Usage

Uses

-helps relieve the local itching and discomfort associated with hemorrhoids

-temporarily shrinks hemorrhoid tissue and relieves burning

-temporarily provides a coating for relief of anorectal discomforts

-temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Dosage and Administration

Directions

adults and children 12 years of age and older for topical use:

-clean the affected area, and oat or dab dry before applying ointment

-apply to the affected area up to 4 times daily, especially after each bowel movement



for intrarectal use:

-attach included applicator to tube

-lubricate applicator tip and gently insert into rectum

-thoroughly clean applicator after each use, and replace cover



children under 12 years of age: ask a doctor before use





Description

beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23, methylparaben, propylparaben, stearyl alcohol Inactive Ingredients

Section 50565-1

. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children



Section 50566-9

Stop use and ask a doctor if

-bleeding occurs

-condition worsens or does not improve within 7 days

-introduction of the applicator into the rectum causes additional pain

Section 50568-5

Ask a doctor or pharmacist before use if you are

-presently taking a prescription drug for high blood pressure

Section 50569-3

Ask a doctor before use if you have

-heart disease

-high blood pressure

-thyroid disease

-diabetes

-trouble urinating due to an enlarged prostate gland

Section 51727-6

beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23, methylparaben, propylparaben, stearyl alcohol Inactive Ingredients

Section 51945-4

Section 53414-9

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

Section 55105-1

Purpose

Protectant

Protectant

Vasoconstrictor

Section 55106-9

Active Ingredient (in each gram)

Mineral oil  14%

Petrolatum  74.9%

Phenylephrine HCI  0.25%

Warnings

For external and/or intrarectal use only


Structured Label Content

Indications and Usage (34067-9)

Uses

-helps relieve the local itching and discomfort associated with hemorrhoids

-temporarily shrinks hemorrhoid tissue and relieves burning

-temporarily provides a coating for relief of anorectal discomforts

-temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Dosage and Administration (34068-7)

Directions

adults and children 12 years of age and older for topical use:

-clean the affected area, and oat or dab dry before applying ointment

-apply to the affected area up to 4 times daily, especially after each bowel movement



for intrarectal use:

-attach included applicator to tube

-lubricate applicator tip and gently insert into rectum

-thoroughly clean applicator after each use, and replace cover



children under 12 years of age: ask a doctor before use





Section 50565-1 (50565-1)

. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children



Section 50566-9 (50566-9)

Stop use and ask a doctor if

-bleeding occurs

-condition worsens or does not improve within 7 days

-introduction of the applicator into the rectum causes additional pain

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

-presently taking a prescription drug for high blood pressure

Section 50569-3 (50569-3)

Ask a doctor before use if you have

-heart disease

-high blood pressure

-thyroid disease

-diabetes

-trouble urinating due to an enlarged prostate gland

Section 51727-6 (51727-6)

beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23, methylparaben, propylparaben, stearyl alcohol Inactive Ingredients

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Protectant

Protectant

Vasoconstrictor

Section 55106-9 (55106-9)

Active Ingredient (in each gram)

Mineral oil  14%

Petrolatum  74.9%

Phenylephrine HCI  0.25%

Warnings

For external and/or intrarectal use only


Advanced Ingredient Data


Raw Label Data

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