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NDC 11822-0006-00 Hemorrhoidal 14; 74.9; .25 g/100g; g/100g; g/100g Details

Hemorrhoidal 14; 74.9; .25 g/100g; g/100g; g/100g

Hemorrhoidal is a RECTAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid Corporation. The primary component is MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE.

Product Information

NDC	11822-0006
Product ID	11822-0006_07e8a5ef-966c-4177-824c-78b7572bb590
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Hemorrhoidal
Proprietary Name Suffix	n/a
Non-Proprietary Name	mineral oil, petrolatum, phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	RECTAL
Active Ingredient Strength	14; 74.9; .25
Active Ingredient Units	g/100g; g/100g; g/100g
Substance Name	MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Rite Aid Corporation
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2024-12-31

Package

Package Images

NDC 11822-0006-00 (11822000600)

Pricing Information	N/A
NDC Package Code	11822-0006-0
Billing NDC	11822000600
Package	1 TUBE in 1 CARTON (11822-0006-0) / 28 g in 1 TUBE
Marketing Start Date	2020-02-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8e1f223a-a3a0-4837-9847-2a3939fcc595 Details

Active ingredients

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Purposes

Protectant

Vasoconstrictor

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

Warnings

For external and/or intrarectal use only

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.

When using this product

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

Stop use and ask a doctor if

•: bleeding occurs
•: condition worsens or does not improve within 7 days
•: introduction of applicator into the 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. (1-800-222-1222)

Directions

•: adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment.
•: apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
•: 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
•: also apply ointment to external area
•: regular use provides continual therapy for relief of symptoms
•: children under 12 years of age: ask a doctor

Inactive ingredients

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thymus vulgaris (thyme) oil, tocopheryl acetate, white wax

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredients of Preparation H® Hemorrhoidal Ointment

PREVENTS FURTHER IRRITATION

HEMORRHOIDAL OINTMENT

MEDICATED FORMULA

prompt, soothing relief from painful burning, itching and discomfort

shrinks swollen hemorrhoidal tissue

protects irritated tissue

relieves internal and external discomfort

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL

mineral oil, petrolatum, phenylephrine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0006
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	.25 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CORN OIL (UNII: 8470G57WFM)
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)
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	YELLOW (light)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-0006-0	1 in 1 CARTON	02/27/2020
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	02/27/2020

Labeler - Rite Aid Corporation (014578892)

Revised: 2/2020

Document Id: 07e8a5ef-966c-4177-824c-78b7572bb590

Set id: 8e1f223a-a3a0-4837-9847-2a3939fcc595

Version: 2

Effective Time: 20200227