TopCare — Ointment

Overview

Brand name

TopCare Hydrocortisone

Generic name

Hydrocortisone

Dosage form

Ointment

Route

Topical

Marketing category

OTC MONOGRAPH DRUG · OTC MONO

Labeler

Topco Associates LLC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

5

NDC product codes

3

Packages

3

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Bacitracin Zinc	500 [iU]/g	204602	View
Hydrocortisone	1 g/100g	604449	View
Neomycin Sulfate	3.5 mg/g	204602	View
Polymyxin B Sulfate	10000 [iU]/g	204602	View
Pramoxine Hydrochloride	10 mg/g	1234532	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Ointment

Route of administration

Topical

Presentations

6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Aminoglycoside Antibacterial [EPC]	EPC	All 66 members
Aminoglycosides [CS]	CS	All 66 members
Corticosteroid Hormone Receptor Agonists [MoA]	MoA	All 215 members
Corticosteroid [EPC]	EPC	All 215 members
Decreased Cell Wall Synthesis & Repair [PE]	PE	All 41 members
Polymyxin-class Antibacterial [EPC]	EPC	All 55 members
Polymyxins [CS]	CS	All 55 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

000004

Application type

M

Approval date

July 16, 1969

Sponsor

PHARMICS

Products on application

1

Submissions recorded

3

Products approved under application 000004.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
000004-004	PAREDRINE	SOLUTION/DROPS		HYDROXYAMPHETAMINE HYDROBROMIDE	Discontinued	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 000004.
Type	No.	Action	Status	Date	Review
Supplement	11	Labeling	Approved	May 26, 1987	—
Supplement	10	Labeling	Approved	May 8, 1980	—
Original application	1		Approved	July 16, 1969	Unknown

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250715). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250715 HUMAN OTC DRUG · 20250715 HUMAN OTC DRUG · 20250707

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should be only under the advice and supervision of a doctor

Purpose

openFDA Drug Labeling

Active ingredients (in each gram) Purpose Bacitracin zinc USP 500 units First aid antibiotic Neomycin sulfate USP 3.5 mg First aid antibiotic Polymyxin B sulfate USP 10,000 units First aid antibiotic Pramoxine HCl USP 10 mg External analgesic

Dosage and Administration

openFDA Drug Labeling

Directions for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Warnings

openFDA Drug Labeling

Warnings For external use only Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use

openFDA Drug Labeling

Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have deep or puncture wounds animal bites serious burns

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each gram) Purpose Bacitracin zinc USP 500 units First aid antibiotic Neomycin sulfate USP 3.5 mg First aid antibiotic Polymyxin B sulfate USP 10,000 units First aid antibiotic Pramoxine HCl USP 10 mg External analgesic

Adverse event reports

Source: openFDA FAERS

123,956

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: HYDROCORTISONE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
36800-018-02	36800-018	Topco Associates LLC	1 TUBE in 1 CARTON (36800-018-02) / 28.4 g in 1 TUBE	October 3, 1989
36800-056-24	36800-056	Topco Associates LLC	1 TUBE in 1 CARTON (36800-056-24) / 28.4 g in 1 TUBE	March 31, 2012
36800-089-02	36800-089	Topco Associates LLC	1 TUBE in 1 CARTON (36800-089-02) / 28.4 g in 1 TUBE	May 11, 2006
36800-018	36800-018	Topco Associates LLC	—	October 3, 1989
36800-056	36800-056	Topco Associates LLC	—	March 31, 2012
36800-089	36800-089	Topco Associates LLC	—	May 11, 2006

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.