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NDC 36800-0279-53 topcare hemorrhoidal 2211; 6.5 mg/1; mg/1 Details

topcare hemorrhoidal 2211; 6.5 mg/1; mg/1

topcare hemorrhoidal is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE.

Product Information

NDC	36800-0279
Product ID	36800-279_4bc5f385-3c5d-4599-b1a0-b2cf53831f94
Associated GPIs	89994002335225
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	topcare hemorrhoidal
Proprietary Name Suffix	n/a
Non-Proprietary Name	cocoa butter, phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	SUPPOSITORY
Route	RECTAL
Active Ingredient Strength	2211; 6.5
Active Ingredient Units	mg/1; mg/1
Substance Name	COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Topco Associates 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	2024-12-31

Package

Package Images

NDC 36800-0279-53 (36800027953)

Pricing Information	N/A
NDC Package Code	36800-279-53
Billing NDC	36800027953
Package	12 BLISTER PACK in 1 CARTON (36800-279-53) / 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date	2014-11-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 81a3546b-5099-4b9a-b774-b3e79316b267 Details

Active ingredients (in each suppository)

Cocoa butter 88.44%

Phenylephrine HCl 0.25%

Purposes

Protectant

Vasoconstrictor

Uses

•: helps relieve the local itching and discomfort associated with hemorrhoids
•: temporarily relieves burning and shrinks hemorrhoidal tissue
•: 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 rectal 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

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 insertion of this product.
•: detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
•: hold suppository with rounded end up
•: see illustrations: carefully separate foil tabs by inserting tip of fingernail at end marked “peel down”
•: slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
•: remove exposed suppository from wrapper
•: 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: ask a doctor

Other information

•: store at 20-25°C (68-77°F)

Inactive ingredients

methylparaben, propylparaben, topical starch

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

TopCare ® health

COMPARE TO PREPARATION H® SUPPOSITORIES ACTIVE INGREDIENTS

NIGHTTIME RELIEF

Hemorrhoidal Suppositories

● Reduces Internal Swelling. Soothes and Protects

● Prompt Soothing Relief from Painful Burning, Itching and Discomfort

● Shrinks Swollen Hemorrhoidal Tissue

● Protects Irritated Tissue

12 SUPPOSITORIES

E-Z OPEN WRAPPER

INGREDIENTS AND APPEARANCE

TOPCARE HEMORRHOIDAL

cocoa butter, phenylephrine hcl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-279
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	2211 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	6.5 mg

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-279-62	24 in 1 CARTON	11/03/2014	03/05/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:36800-279-53	12 in 1 CARTON	11/03/2014
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	11/03/2014

Labeler - Topco Associates LLC (006935977)

Revised: 9/2022

Document Id: 4bc5f385-3c5d-4599-b1a0-b2cf53831f94

Set id: 81a3546b-5099-4b9a-b774-b3e79316b267

Version: 6

Effective Time: 20220921