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NDC 70795-1021-04 Hemorrhoidal 1768.8; 5 mg/1; mg/1 Details

Hemorrhoidal 1768.8; 5 mg/1; mg/1

Hemorrhoidal is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by GRAXCELL PHARMACEUTICAL, LLC. The primary component is COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE.

Product Information

NDC	70795-1021
Product ID	70795-1021_d3aed0a8-899f-525c-e053-2995a90a7d37
Associated GPIs	89994002335225
GCN Sequence Number	071662
GCN Sequence Number Description	phenylephrine HCl/cocoa butter SUPP.RECT 0.25-88.44 RECTAL
HIC3	Q3D
HIC3 Description	HEMORRHOIDAL PREPARATIONS
GCN	35585
HICL Sequence Number	040185
HICL Sequence Number Description	PHENYLEPHRINE HCL/COCOA BUTTER
Brand/Generic	Generic
Proprietary Name	Hemorrhoidal
Proprietary Name Suffix	n/a
Non-Proprietary Name	COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SUPPOSITORY
Route	RECTAL
Active Ingredient Strength	1768.8; 5
Active Ingredient Units	mg/1; mg/1
Substance Name	COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	GRAXCELL PHARMACEUTICAL, LLC
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	2023-12-31

Package

Package Images

NDC 70795-1021-04 (70795102104)

Pricing Information	N/A
NDC Package Code	70795-1021-4
Billing NDC	70795102104
Package	24 BLISTER PACK in 1 BOX (70795-1021-4) / 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date	2017-04-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5162baee-0d63-494e-8046-459437b85348 Details

Active Ingredients (per suppository)

Cocoa butter 88.44 %

Phenylephrine hydrochloride 0.25 %

Purpose

Protectant

Vasoconstructor

Uses

temporarily shrinks hemorrhoidal tissues
gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
aids in protecting irritated anorectal areas

Warnings

For rectal use only

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression

Ask a doctor before use if you have

heart disease
thyroid disease
high blood pressure
diabetes
difficulty in urination due to enlargement of the prostate gland

When using this product

do not exceed the recommended daily dosage unless directed by a doctor
in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly

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.

Directions Adults

detach one suppository from the strip. Remove the wrapper before inserting into the rectum.
insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement. Children under 12 years of age: consult doctor

Other Information

Store at room temperature or in a cool place but not over 80° F

Inactive ingredients

methylparaben, propylparaben, starch

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL

cocoa butter, phenylephrine hydrochloride suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70795-1021
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	1768.8 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STARCH, CORN (UNII: O8232NY3SJ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70795-1021-2	12 in 1 BOX	03/29/2017
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:70795-1021-4	24 in 1 BOX	04/22/2017
2		1 in 1 BLISTER PACK; 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	03/29/2017

Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)

Registrant - GRAXCELL PHARMACEUTICAL, LLC. (056556923)

Revised: 12/2021

Document Id: d3aed0a8-899f-525c-e053-2995a90a7d37

Set id: 5162baee-0d63-494e-8046-459437b85348

Version: 7

Effective Time: 20211221