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NDC 36800-0499-16 topcare hemorrhoidal 14; 74.9; .25 g/100g; g/100g; g/100g Details

topcare hemorrhoidal 14; 74.9; .25 g/100g; g/100g; g/100g

topcare hemorrhoidal is a RECTAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE.

Product Information

NDC	36800-0499
Product ID	36800-499_4a79203a-e616-4e6b-9072-8308a4b30406
Associated GPIs	89994003224222
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	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	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 36800-0499-16 (36800049916)

Pricing Information	N/A
NDC Package Code	36800-499-16
Billing NDC	36800049916
Package	1 TUBE in 1 CARTON (36800-499-16) / 57 g in 1 TUBE
Marketing Start Date	2014-03-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 615e87e4-79e0-44d6-b563-3bcd5a9b2d93 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

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?

1-888-423-0139

Package/Label Principal Display Panel

TopCare® health

COMPARE TO PREPARATION H® OINTMENT ACTIVE INGREDIENTS

Hemorrhoidal Ointment

PREVENTS FURTHER IRRITATION

• Rapid Soothing Pain Relief from Painful Burning, Itching and Discomfort

• Shrinks Swollen Hemorrhoidal Tissue

• Protects Irritated Tissue

• Relieves External Discomfort

NET WT 2 OZ (57g)

INGREDIENTS AND APPEARANCE

TOPCARE HEMORRHOIDAL

mineral oil, petrolatum, phenylephrine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-499
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:36800-499-16	1 in 1 CARTON	03/28/2014
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	03/28/2014

Labeler - Topco Associates LLC (006935977)

Revised: 2/2022

Document Id: 4a79203a-e616-4e6b-9072-8308a4b30406

Set id: 615e87e4-79e0-44d6-b563-3bcd5a9b2d93

Version: 3

Effective Time: 20220222