Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 80863615-a588-4178-a329-757f6530431e
Routes
TOPICAL RECTAL
Published
Effective Date 2013-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (10.4 g) Ferric Oxide Red (0.05 g) Phenylephrine (0.25 g) Petrolatum (79.25 g)
Inactive Ingredients
Amber Lanolin Sodium Borate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-08-28

Description

Active ingredients Calamine 10.5% Petrolatum 79.25% Phenylephrine hydrochloride 0.25%


Medication Information

Warnings and Precautions

Warnings

For rectal use only

Indications and Usage

Uses

temporarily helps relieve:

anorectal burning, itching, and discomfort associated with hemorrhoids

temporarily:

reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders

shrinks hemorrhoidal tissue

protects inflamed perianal skin and irritated areas

Dosage and Administration

Directions

adults: 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 a soft cloth before application of this product.

For external hemorrhoids, apply a small amount of ointment directly to the affected area up to 4 times daily.

FOR INTRARECTAL USE (internal hemorrhoids): Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Squeeze a small amount (2 g) of the ointment into the rectum. Remove and discard used applicator. Apply to the affected area up to 4 times daily.

children under 12 years of age: consult a doctor.

Description

Active ingredients Calamine 10.5% Petrolatum 79.25% Phenylephrine hydrochloride 0.25%

Section 44425-7

Other information

keep container tightly closed

store at room temperature 20 - 25º C (68 - 77º F)

do not use if the physical properties of this product have changed

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

condition worsens

symptoms do not improve within 7 days

Section 50567-7

When using this product

in case of bleeding; consult a doctor promptly

do not exceed the recommended daily dosage unless directed by a doctor

do not use with an applicator if the introduction of the applicator into the rectum causes

additional pain. Consult a doctor promptly.

Section 50568-5

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression

Section 50569-3

Ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

difficulty in urination due to enlargement of the prostate gland

Section 51727-6

Inactive ingredients

Amber, lanolin, pearl, and sodium borate.

Section 51945-4

MAYINGLONG BEZORNIL HEMORRHOIDAL OINTMENT  NDC 30803-001-01  0.353 oz (10 g)

Section 53413-1

Questions or comments?

(888) 221-3496 M-F 9 am to 5 pm

Section 53414-9

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

Section 55105-1

Purpose

Hemorrhoidal (anorectal) astringent/protectant

Hemorrhoidal (anorectal) protectant

Hemorrhoidal (anorectal) vasoconstrictor

Section 55106-9

Active ingredients

Calamine 10.5%

Petrolatum 79.25%

Phenylephrine hydrochloride 0.25%


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily helps relieve:

anorectal burning, itching, and discomfort associated with hemorrhoids

temporarily:

reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders

shrinks hemorrhoidal tissue

protects inflamed perianal skin and irritated areas

Dosage and Administration (34068-7)

Directions

adults: 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 a soft cloth before application of this product.

For external hemorrhoids, apply a small amount of ointment directly to the affected area up to 4 times daily.

FOR INTRARECTAL USE (internal hemorrhoids): Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Squeeze a small amount (2 g) of the ointment into the rectum. Remove and discard used applicator. Apply to the affected area up to 4 times daily.

children under 12 years of age: consult a doctor.

Warnings and Precautions (34071-1)

Warnings

For rectal use only

Section 44425-7 (44425-7)

Other information

keep container tightly closed

store at room temperature 20 - 25º C (68 - 77º F)

do not use if the physical properties of this product have changed

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

condition worsens

symptoms do not improve within 7 days

Section 50567-7 (50567-7)

When using this product

in case of bleeding; consult a doctor promptly

do not exceed the recommended daily dosage unless directed by a doctor

do not use with an applicator if the introduction of the applicator into the rectum causes

additional pain. Consult a doctor promptly.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression

Section 50569-3 (50569-3)

Ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

difficulty in urination due to enlargement of the prostate gland

Section 51727-6 (51727-6)

Inactive ingredients

Amber, lanolin, pearl, and sodium borate.

Section 51945-4 (51945-4)

MAYINGLONG BEZORNIL HEMORRHOIDAL OINTMENT  NDC 30803-001-01  0.353 oz (10 g)

Section 53413-1 (53413-1)

Questions or comments?

(888) 221-3496 M-F 9 am to 5 pm

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Hemorrhoidal (anorectal) astringent/protectant

Hemorrhoidal (anorectal) protectant

Hemorrhoidal (anorectal) vasoconstrictor

Section 55106-9 (55106-9)

Active ingredients

Calamine 10.5%

Petrolatum 79.25%

Phenylephrine hydrochloride 0.25%


Advanced Ingredient Data


Raw Label Data

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