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NDC 45802-0188-16 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 Padagis Israel Pharmaceuticals Ltd. The primary component is MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE.

Product Information

NDC	45802-0188
Product ID	45802-188_1b107433-faf1-45b2-a175-bf2301060be0
Associated GPIs	89994003224222
GCN Sequence Number	071294
GCN Sequence Number Description	phenyleph/mineral oil/petrolat OINT/APPL 0.25 %-14% RECTAL
HIC3	Q3D
HIC3 Description	HEMORRHOIDAL PREPARATIONS
GCN	35039
HICL Sequence Number	039599
HICL Sequence Number Description	PHENYLEPHRINE HCL/MINERAL OIL/PETROLATUM,WHITE
Brand/Generic	Generic
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	Padagis Israel Pharmaceuticals Ltd
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 45802-0188-16 (45802018816)

Pricing Information
NDC Package Code	45802-188-16
Billing NDC	45802018816
Package	1 TUBE in 1 CARTON (45802-188-16) / 57 g in 1 TUBE
Marketing Start Date	2013-11-01
NDC Exclude Flag	N
Price Per Unit	0.05291
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	HEMORRHOIDAL OINTMENT
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 43826c68-0a20-460d-a7b5-f3e12395a7d0 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.
•: when first opening the tube, puncture foil seal with top end of cap
•: 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

Other information

•: store at 20-25°C (68-77°F)

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 Preparation H® Ointment active ingredients

Hemorrhoidal Ointment

Prevents Further Irritation

Prompt, soothing relief from painful burning, itching and discomfort

Shrinks swollen hemorrhoidal tissue

Protects irritated tissue

Relieves internal and external discomfort

NET WT 2 OZ (57 g)

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL

mineral oil, petrolatum, phenylephrine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45802-188
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:45802-188-16	1 in 1 CARTON	11/01/2013
1		57 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	11/01/2013

Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 11/2021

Document Id: 1b107433-faf1-45b2-a175-bf2301060be0

Set id: 43826c68-0a20-460d-a7b5-f3e12395a7d0

Version: 3

Effective Time: 20211108