SPL v3
SPL
SPL Set ID cfdd61e3-e12e-491c-b2a8-90fae19e8870
Route
TOPICAL
Published
Effective Date 2017-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (14 g) Petrolatum (74.9 g) Phenylephrine (0.25 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 2017-03-30

Description

Active ingredients (in each gram) Mineral oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25%


Medication Information

Warnings and Precautions

Warnings

For external and/or intrarectal use only

Ask a doctor before use if you have

•heart disease  •high blood pressure  •thyroid disease  •diabetes  •trouble urinating due to

an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure.

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.

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

Indications and Usage

•helps relieve the local itching and discomfort associated with hemorrhoids. Uses

•Temporarily shrinks hemorrhoid tissue and relieves burning.

•Temporarily provides a coating for relief of anorectal burning.

•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 pat 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

Active ingredients (in each gram) Mineral oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25%

Section 50565-1

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

away.

Section 51727-6

  beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23, Inactive ingredients

methylparaben, propylparaben, stearyl alcohol

Section 51945-4

Section 53413-1

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

Section 55105-1

Purposes

Protectant

Protectant

Vasoconstrictor

Section 55106-9

Active ingredients (in each gram)

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

•helps relieve the local itching and discomfort associated with hemorrhoids. Uses

•Temporarily shrinks hemorrhoid tissue and relieves burning.

•Temporarily provides a coating for relief of anorectal burning.

•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 pat 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.

Warnings and Precautions (34071-1)

Warnings

For external and/or intrarectal use only

Ask a doctor before use if you have

•heart disease  •high blood pressure  •thyroid disease  •diabetes  •trouble urinating due to

an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure.

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.

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

Section 50565-1 (50565-1)

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

away.

Section 51727-6 (51727-6)

  beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23, Inactive ingredients

methylparaben, propylparaben, stearyl alcohol

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)

Purposes

Protectant

Protectant

Vasoconstrictor

Section 55106-9 (55106-9)

Active ingredients (in each gram)

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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