HEB HEMORRHOIDAL- mineral oil, petrolatum, and phenylephrine hydrochloride cream

HEB Hemorrhoidal by

Drug Labeling and Warnings

HEB Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by H-E-B, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Mineral Oil 14%	Protectant
Petrolatum 74.9%	Protectant
Phenylephrine hydrochloride 0.25%	Vasoconstrictor

Uses

• For the temporary relief of anorectal itching and discomfort associated with hemorrhoids.
• Temporarily reduces swelling associated with irritation in hemorrhoids and other anorectal disorders
• Temporarily shrinks hemorrhoidal tissue
• Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
• Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

For external and/or intrarectal use only

Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Ask a doctor or pharmacist before use if you are

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

When using this product

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

Stop use and ask a physician if

• bleeding occurs
• condition worsens or does not improve within 7 days
• introduction of applicator into rectum causes additional pain

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

• Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with a tissue or a soft cloth before application of this product
• apply externally to the affected area up to 4 times daily
• intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover
• Children under 12 years of age: consult a physician

Other information

• Store at 15 to 30°C(59 to 86°F)
• Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

Benzoic acid, cera alba (bees wax), glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, purified water, thymus vulgaris (thyme) oil, tocopherol (vitamin E) acetate

Questions or comments?

866-323-0107

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

Compare to Preperation H® Ointment active ingredients*

H-E-B ®

NDC: 37808-991-24

Hemorrhoidal Ointment
Mineral Oil / Petrolatum / Protectant
Phenylephrine Hydrochloride / Vasoconstrictor

Includes
Dispensing
Cap

Hemorrhoid Symptom Relief

• Helps Relieve Pain & Itching
• Lubricating Coating Protects Irritated Tissue

NET WT 2.0 OZ (56.7 g)

INGREDIENTS AND APPEARANCE

HEB HEMORRHOIDAL 
mineral oil, petrolatum, and phenylephrine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-991
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP)	Mineral Oil	14 g  in 100 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	74.9 g  in 100 g
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	0.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Benzoic Acid (UNII: 8SKN0B0MIM)
White Wax (UNII: 7G1J5DA97F)
Glycerin (UNII: PDC6A3C0OX)
Lanolin (UNII: 7EV65EAW6H)
Lanolin Alcohols (UNII: 884C3FA9HE)
Methylparaben (UNII: A2I8C7HI9T)
Paraffin (UNII: I9O0E3H2ZE)
Propylparaben (UNII: Z8IX2SC1OH)
Water (UNII: 059QF0KO0R)
Thyme Oil (UNII: 2UK410MY6B)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-991-24	1 in 1 CARTON	10/23/2018
1		56.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	10/23/2018

Labeler - H-E-B (007924756)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(37808-991)