Family Wellness — Ointment

Overview

Brand name

Family Wellness

Generic name

Bacitracin Zinc

Dosage form

Ointment

Route

Topical

Marketing category

OTC MONOGRAPH DRUG · OTC MONO

Labeler

FRONT PHARMACEUTICAL PLC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

7

NDC product codes

4

Packages

4

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	.41 g/100g	204602	View
Bacitracin Zinc	.51 g/100g	204602	View
Mineral Oil	14 g/100g	706820	—
Neomycin Sulfate	.0035 g/100g	204602	View
Petrolatum	74.9 g/100g	706820	View
Phenylephrine Hydrochloride	.25 g/100g	1232651	View
Polymyxin B Sulfate	.52 g/100g	204602	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Ointment

Route of administration

Topical

Presentations

8

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
Adrenergic alpha1-Agonists [MoA]	MoA	9 members — no class page
Aminoglycoside Antibacterial [EPC]	EPC	All 66 members
Aminoglycosides [CS]	CS	All 66 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
alpha-1 Adrenergic Agonist [EPC]	EPC	9 members — no class page

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 20231027). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20231027 HUMAN OTC DRUG · 20231027 HUMAN OTC DRUG · 20231025

Indications and Usage

openFDA Drug Labeling

Uses - Helps relieve the local itching and discomfort associated with hemorrhoids. -Temporarily shrinks hemorrhoid 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

Purpose

openFDA Drug Labeling

Purpose First aid antibiotic First aid antibiotic First aid antibiotic

Dosage and Administration

openFDA Drug Labeling

Directions Adults and children 12 years of age and older for topical use: •clean the affected area, and pat or dab dry before applying ointment. •apply to the affected area up to 4 times daily, especially after each bowel movement. For intrarectal use: •attach included applicator to tube. •lubricate applicator tip and gently insert into rectum •thoroughly clean applicator after each use, and replace cover Children under 12 years of age: ask a doctor before use.

Warnings

openFDA Drug Labeling

Warnings For external and/or intrarectal use only Ask a doctor before use if you have •heart disease •high blood pressure •thyroid disease •diabetes •trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure. Stop use and ask a doctor if •bleeding occurs •condition worsens or does not improve within 7 days. •introduction of the applicator into the rectum causes additional pain. , ask a health professional before use. If pregnant or breast-feeding

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have - heart disease -high blood pressure -thyroid disease -diabetes -trouble urinating due to an enlarged prostate gland

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if -bleeding occurs -condition worsens or does not improve within 7 days. -Introduction of the appllicator into the rectum causes additional pain

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each gram) Bacitracin 400 units Neomycin 3.5 mg Polymyxin B 5,000 units

Adverse event reports

Source: openFDA FAERS

168,591

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: PHENYLEPHRINE HYDROCHLORIDE. 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
69571-003-02	69571-003	FRONT PHARMACEUTICAL PLC	1 TUBE in 1 BOX (69571-003-02) / 28 g in 1 TUBE (69571-003-01)	February 22, 2017
69571-006-02	69571-006	FRONT PHARMACEUTICAL PLC	1 TUBE in 1 BOX (69571-006-02) / 57 g in 1 TUBE (69571-006-01)	March 30, 2017
69571-008-01	69571-008	FRONT PHARMACEUTICAL PLC	1 TUBE in 1 CARTON (69571-008-01) / 28 g in 1 TUBE	June 13, 2017
55621-006-01	55621-006	Zhejiang Jingwei Pharmaceutical Co., Ltd.	1 TUBE in 1 BOX (55621-006-01) / 57 g in 1 TUBE	November 1, 2013
69571-003	69571-003	FRONT PHARMACEUTICAL PLC	—	February 22, 2017
69571-006	69571-006	FRONT PHARMACEUTICAL PLC	—	March 30, 2017
69571-008	69571-008	FRONT PHARMACEUTICAL PLC	—	June 13, 2017
55621-006	55621-006	Zhejiang Jingwei Pharmaceutical Co., Ltd.	—	November 1, 2013

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.