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Antibiotic and Pain Relief

Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride · Cream

Over-the-counter M Official labelling

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

Antibiotic and Pain Relief

Generic name

Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride

Dosage form

Cream

Route

Topical

Marketing category

OTC MONOGRAPH DRUG · OTC MONO

Labeler

STRATEGIC SOURCING SERVICES LLC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

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
Neomycin Sulfate	3.5 mg/g	204602	View
Polymyxin B Sulfate	10000 [USP'U]/g	204602	View
Pramoxine Hydrochloride	10 mg/g	1234532	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Cream

Route of administration

Topical

Presentations

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
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

Approval date

July 16, 1969

Sponsor

PHARMICS

Products on application

Submissions recorded

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 20260318). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260318 HUMAN OTC DRUG · 20241014

Indications and Usage

openFDA Drug Labeling

Uses first aid to help prevent infection and for temporary relief of pain or discomfort in minor: • cuts • scrapes • burns

Purpose

openFDA Drug Labeling

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

Dosage and Administration

openFDA Drug Labeling

Directions • adults and children 2 years of age or older: • clean the affected area • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily • may be covered with a sterile bandage • children under 2 years of age: ask a doctor

Warnings

openFDA Drug Labeling

Warnings For external use only. Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • symptoms persist for more than 1 week, or clear up and occur again within a few days • rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Do Not Use

openFDA Drug Labeling

Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body

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 • you need to use longer than 1 week • condition persists or gets worse • symptoms persist for more than 1 week, or clear up and occur again within a few days • rash or other allergic reaction develops

Active Ingredient

openFDA Drug Labeling

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

Adverse event reports

Source: openFDA FAERS

4,875

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: POLYMYXIN B SULFATE. 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
69842-754-58	69842-754	CVS Pharmacy	1 TUBE in 1 CARTON (69842-754-58) / 14 g in 1 TUBE	February 5, 2021
69842-754-64	69842-754	CVS Pharmacy	1 TUBE in 1 CARTON (69842-754-64) / 28 g in 1 TUBE	February 5, 2021
70677-1218-1	70677-1218	STRATEGIC SOURCING SERVICES LLC	1 TUBE in 1 CARTON (70677-1218-1) / 14.2 g in 1 TUBE	January 24, 2024
11673-770-14	11673-770	Target Corporation	1 TUBE in 1 CARTON (11673-770-14) / 14 g in 1 TUBE	January 31, 2024
69842-754	69842-754	CVS Pharmacy	—	February 5, 2021
70677-1218	70677-1218	STRATEGIC SOURCING SERVICES LLC	—	January 24, 2024
11673-770	11673-770	Target Corporation	—	January 31, 2024

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.