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NDC 41415-0076-75 Publix 3.5; 10000; 10 mg/g; [iU]/g; mg/g Details

Publix 3.5; 10000; 10 mg/g; [iU]/g; mg/g

Publix is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Publix Super Markets Inc. The primary component is NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE.

Product Information

NDC	41415-0076
Product ID	41415-076_13064d7b-9592-41ab-9c53-c01900a58572
Associated GPIs	66100060100303
GCN Sequence Number	021980
GCN Sequence Number Description	naproxen sodium TABLET 220 MG ORAL
HIC3	S2B
HIC3 Description	NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS
GCN	47132
HICL Sequence Number	003726
HICL Sequence Number Description	NAPROXEN SODIUM
Brand/Generic	Generic
Proprietary Name	Publix
Proprietary Name Suffix	antibiotic plus Pain Relief
Non-Proprietary Name	Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	3.5; 10000; 10
Active Ingredient Units	mg/g; [iU]/g; mg/g
Substance Name	NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Labeler Name	Publix Super Markets Inc
Pharmaceutical Class	Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333B
Listing Certified Through	2023-12-31

Package

Package Images

NDC 41415-0076-75 (41415007675)

Pricing Information	N/A
NDC Package Code	41415-076-75
Billing NDC	41415007675
Package	1 TUBE in 1 CARTON (41415-076-75) / 28.4 g in 1 TUBE
Marketing Start Date	2012-03-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d0193bf1-a257-490e-a058-5e6a514981da Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

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

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in

minor cuts
scrapes
burns

Warnings

For external use only

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

Ask a doctor before use

on deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

condition gets worse
condition persists for more than 7 days
condition clears up and occurs again within a few days
a 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.

Directions

Adults and children 2 years of age and older:

clean the affected area and dry thoroughly
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: consult a doctor

Other information

To open: unscrew cap, pull tab to remove foil seal
store at controlled room temperature
see carton or tube crimp for lot number and expiration date

Inactive ingredients

emulsifying wax, methylparaben, mineral oil, propylene glycol, purified water, white petrolatum

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY PUBLIX

SUPER MARKETS, INC.

3300 PUBLIX CORPORATE

PARKWAY

LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Publix

antibioticcream+

PAIN

RELIEF

NEOMYCIN SULFATE • POLYMYXIN B SULFATE • PRAMOXINE HCl

FIRST AID ANTIBIOTIC CREAM PLUS PAIN RELIEVER

NET WT 1 OZ (28.4g)

Principal Display Panel - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

PUBLIX ANTIBIOTIC PLUS PAIN RELIEF

neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41415-076
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Neomycin sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	3.5 mg in 1 g
Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B	10000 [iU] in 1 g
Pramoxine hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine hydrochloride	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41415-076-75	1 in 1 CARTON	03/21/2012
1		28.4 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	part333B	03/21/2012

Labeler - Publix Super Markets Inc (006922009)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(41415-076)

Revised: 12/2021

Document Id: 13064d7b-9592-41ab-9c53-c01900a58572

Set id: d0193bf1-a257-490e-a058-5e6a514981da

Version: 2

Effective Time: 20211214

Search by Drug Name or NDC

NDC 41415-0076-75 Publix 3.5; 10000; 10 mg/g; [iU]/g; mg/g Details

Publix 3.5; 10000; 10 mg/g; [iU]/g; mg/g

Product Information

Package

Package Images

NDC 41415-0076-75 (41415007675)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d0193bf1-a257-490e-a058-5e6a514981da Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

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