Hemorrhoidal, A+ Health

Hemorrhoidal, A+ Health
SPL v1
SPL
SPL Set ID 1790da99-2a22-e2a2-e063-6394a90ac36f
Route
TOPICAL
Published
Effective Date 2024-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (749 mg) Phenylephrine (2.5 mg) Mineral Oil (140 mg)
Inactive Ingredients
.alpha.-tocopherol Acetate White Wax Benzoic Acid Butylated Hydroxyanisole Corn Oil Lanolin Glycerin Lanolin Alcohols Methylparaben Water Paraffin Propylparaben Thyme Oil

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-10

Description

Mineral Oil 14% Petrolatum 74.9% Phenylephrine HCI 0.25%

Purpose

Protectant Protectant Vasoconstrictor


Medication Information

Purpose

Protectant

Protectant

Vasoconstrictor

Description

Mineral Oil 14% Petrolatum 74.9% Phenylephrine HCI 0.25%

Uses

■ Helps relieve the local itching and discomfort associated with hemorrhoids

■ Temporarily shrinks hemorrhoidal 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

Section 42229-5

READ AND KEEP CARTON FOR COMPLETE INFORMATION

*This product is not manufactured or distributed by the owners of Preparation H® Hemorrhoidal Ointment.

Manufactured for: Bionpharma Inc., Princeton, NJ 08540

GUJ/DRUGS/G/25/2134

MADE IN INDIA

L0000812

R0424

LOT & EXP.

Warnings

For external and/or intrarectal use only

Directions

Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying ointment.

■ Apply to affected areas up to 4 times daily.

■ EXTERNAL USE: Apply to affected area

■ FOR INTRARECTAL USE: ■ Remove cover from the applicator ■ Attach applicator to tube ■ Lubricate applicator well, then gently insert applicator into the rectum ■ Thoroughly clean applicator after each use and replace cover

Children under 12 years of age: consult a doctor

Tube Carton

*compare to the active ingredient in Preparation H ® Hemorrhoid Treatment Ointment

NDC 69452-448-38

a+ health TM

hemorrhoidal ointment

• reduces irritation • with applicator

dye-free • phthalate-free • fragrance-free

• relieves both internal and external hemorrhoid symptoms

• temporarily shrinks swollen hemorrhoidal tissue

• prompt, soothing relief from painful burning, itching and discomfort

net wt. 2 oz

Active Ingredient

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCI 0.25%

Other Information

■ Store at 15°C – 30°C (59°F – 86°F)

■ Lot No. & Expiry Date: See box or crimp of tube

Inactive Ingredients

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thyme oil, vitamin E, white wax

When Using This Product

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

Stop Use and Ask A Doctor If

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

■ introduction of applicator into the rectum causes additional pain

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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

Ask A Doctor Or Pharmacist Before Use If You

are presently taking a prescription drug for high blood pressure or depression.


Structured Label Content

Uses

■ Helps relieve the local itching and discomfort associated with hemorrhoids

■ Temporarily shrinks hemorrhoidal 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

Section 42229-5 (42229-5)

READ AND KEEP CARTON FOR COMPLETE INFORMATION

*This product is not manufactured or distributed by the owners of Preparation H® Hemorrhoidal Ointment.

Manufactured for: Bionpharma Inc., Princeton, NJ 08540

GUJ/DRUGS/G/25/2134

MADE IN INDIA

L0000812

R0424

LOT & EXP.

Purpose

Protectant

Protectant

Vasoconstrictor

Warnings

For external and/or intrarectal use only

Directions

Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying ointment.

■ Apply to affected areas up to 4 times daily.

■ EXTERNAL USE: Apply to affected area

■ FOR INTRARECTAL USE: ■ Remove cover from the applicator ■ Attach applicator to tube ■ Lubricate applicator well, then gently insert applicator into the rectum ■ Thoroughly clean applicator after each use and replace cover

Children under 12 years of age: consult a doctor

Tube Carton (tube carton)

*compare to the active ingredient in Preparation H ® Hemorrhoid Treatment Ointment

NDC 69452-448-38

a+ health TM

hemorrhoidal ointment

• reduces irritation • with applicator

dye-free • phthalate-free • fragrance-free

• relieves both internal and external hemorrhoid symptoms

• temporarily shrinks swollen hemorrhoidal tissue

• prompt, soothing relief from painful burning, itching and discomfort

net wt. 2 oz

Active Ingredient (Active ingredient)

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCI 0.25%

Other Information (Other information)

■ Store at 15°C – 30°C (59°F – 86°F)

■ Lot No. & Expiry Date: See box or crimp of tube

Inactive Ingredients (Inactive ingredients)

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thyme oil, vitamin E, white wax

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

■ introduction of applicator into the rectum causes additional pain

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding, (If pregnant or breast- feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (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

Ask A Doctor Or Pharmacist Before Use If You (Ask a doctor or pharmacist before use if you)

are presently taking a prescription drug for high blood pressure or depression.


Advanced Ingredient Data


Raw Label Data

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