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NDC 70000-0390-01 leader triple antibiotic and pain relief 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g Details

leader triple antibiotic and pain relief 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g

leader triple antibiotic and pain relief is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. The primary component is BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Neomycin, polymyxin, and bacitracin combination is used to prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Neomycin, polymyxin, and bacitracin are in a class of medications called antibiotics. Neomycin, polymyxin, and bacitracin combination works by stopping the growth of bacteria.

Related Packages: 70000-0390-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.

Related Packages: 70000-0390-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pramoxine

Product Information

NDC	70000-0390
Product ID	70000-0390_2fb4e4f2-a5cc-4a7c-9239-ece2c46a8ac0
Associated GPIs	90109804434220
GCN Sequence Number	047690
GCN Sequence Number Description	neomycn/bacitrc/polymyx/pramox OINT. (G) 3.5-10K-10 TOPICAL
HIC3	Q5W
HIC3 Description	TOPICAL ANTIBIOTICS
GCN	12623
HICL Sequence Number	035595
HICL Sequence Number Description	NEOMYCIN SULF/BACITRACIN ZINC/POLYMYXIN B SULF/PRAMOXINE HCL
Brand/Generic	Generic
Proprietary Name	leader triple antibiotic and pain relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	500; 3.5; 10000; 10
Active Ingredient Units	[USP'U]/g; mg/g; [USP'U]/g; mg/g
Substance Name	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Labeler Name	Cardinal Health 110, LLC. dba Leader
Pharmaceutical Class	Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333B
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0390-01 (70000039001)

Pricing Information
NDC Package Code	70000-0390-1
Billing NDC	70000039001
Package	1 TUBE in 1 CARTON (70000-0390-1) / 28 g in 1 TUBE
Marketing Start Date	2018-12-13
NDC Exclude Flag	N
Price Per Unit	0.11192
Pricing Unit	GM
Effective Date	2023-03-22
NDC Description	TRIPLE ANTIBIOTIC-PAIN OINT
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 6825fc59-ddc0-435d-b83f-0840f869d288 Details

Active ingredients (in each gram)

Bacitracin zinc 500 units

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

Pramoxine HCl 10 mg

Purpose

First aid antibiotic

External analgesic

Uses

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

•: cuts
•: scrapes
•: burns

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)

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

Other information

•: store at 20-25°C (68-77°F)

Inactive ingredient

white petrolatum

Questions or comments?

1-800-719-9260

Principal Display Panel

Maximum Strength

Triple Antibiotic Ointment + Pain Relief

Bacitracin Zinc | Neomycin Sulfate | Polymyxin B Sulfate | Pramoxine HCl

COMPARE TO NEOSPORIN® + PAIN RELIEF active ingredients

First Aid Antibiotic Pain Relieving Ointment

Soothes Cuts, Scrapes and Burns

100% Money Back Guarantee

NET WT 1 OZ (28 g)

triple antibiotic ointment plus pain relief image

INGREDIENTS AND APPEARANCE

LEADER TRIPLE ANTIBIOTIC AND PAIN RELIEF

bacitracin, neomycin, polymyxin b, pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0390
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U] in 1 g
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 [USP'U] in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	YELLOW (Translucent)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0390-1	1 in 1 CARTON	12/13/2018
1		28 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	12/13/2018

Labeler - Cardinal Health 110, LLC. dba Leader (063997360)

Revised: 6/2021

Document Id: 2fb4e4f2-a5cc-4a7c-9239-ece2c46a8ac0

Set id: 6825fc59-ddc0-435d-b83f-0840f869d288

Version: 3

Effective Time: 20210617