Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID bfa195d7-d87f-43b5-bbf1-7ec3a451de05
Routes
TOPICAL RECTAL
Published
Effective Date 2013-09-04
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 2013-11-01

Description

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


Medication Information

Warnings and Precautions

Warnings

For external and/or intrarectal use only

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 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

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

Section 44425-7

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

Section 50565-1

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

right away

Section 50566-9

Stop use and ask a doctor if

-bleeding occurs

-condition worsens or does not improve within 7 days.

-Introduction of the appllicator into the rectum causes additional pain

Section 50568-5

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug due to 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

Inactive Ingredients - beeswax, benzoic acid, cetyl alcohol, glycerin,

laureth - 23, methylparaben, propylparaben, stearyl alcohol

Section 51945-4

Section 53413-1

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

Section 53414-9

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

Section 55105-1

Purposes

--- Protectant

---Protectant

---Vasoconstrictor



Section 55106-9

Active Ingredients (in each gram)

Mineral oil 14 %

Petrolatum 74.9 %

Phenylephrine HCI  0,25 %


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 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

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

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

right away

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 appllicator 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 due to 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)

Inactive Ingredients - beeswax, benzoic acid, cetyl alcohol, glycerin,

laureth - 23, methylparaben, propylparaben, stearyl alcohol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

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 HCI  0,25 %


Advanced Ingredient Data


Raw Label Data

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