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NDC 70000-0334-01 Leader Zinc Oxide 200 mg/g Details

Leader Zinc Oxide 200 mg/g

Leader Zinc Oxide is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110,Inc.. The primary component is ZINC OXIDE.

Product Information

NDC	70000-0334
Product ID	70000-0334_6a6c2b6c-078c-4816-a9bc-1e03130793cf
Associated GPIs	90971020004210
GCN Sequence Number	005576
GCN Sequence Number Description	zinc oxide OINT. (G) 20 % TOPICAL
HIC3	L3A
HIC3 Description	PROTECTIVES
GCN	22080
HICL Sequence Number	002361
HICL Sequence Number Description	ZINC OXIDE
Brand/Generic	Generic
Proprietary Name	Leader Zinc Oxide
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	200
Active Ingredient Units	mg/g
Substance Name	ZINC OXIDE
Labeler Name	Cardinal Health 110,Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0334-01 (70000033401)

Pricing Information
NDC Package Code	70000-0334-1
Billing NDC	70000033401
Package	454 g in 1 JAR (70000-0334-1)
Marketing Start Date	2019-03-29
NDC Exclude Flag	N
Price Per Unit	0.01521
Pricing Unit	GM
Effective Date	2024-01-17
NDC Description	ZINC OXIDE 20% OINTMENT
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 4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1 Details

Drug Facts

Active Ingredient

Zinc oxide 20%

Purpose

Skin Protectant

Uses

helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

For external use only

When using this product, avoid contact with the eyes

Stop use and ask a doctor if

condition worsens
symptoms last more than 7 days to clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

apply liberally as often as necessary

For Diaper Rash

change wet or soiled diapers promptly
cleanse the diaper area and allow to dry
apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

For Poison Ivy, poison oak and poison sumac;

cleanse the affect area and pat dry
apply ointment liberally, as often as necessary, using a cotton ball, sterile swab or gauze
wash hands after use.

Inactive ingredients

mineral oil, petrolatum

Questions or comments?

Call 1-800-222-1087

Store at room temperature 20 - 25°C (68° - 77°F).

Principal Display Panel – Jar Label

Leader® NDC 70000-0334-1

Zinc Oxide

Ointment USP•

Multi Purpose Skin Protectant

provides soothing relief from poison ivy,

oak and sumac

Treats and prevents diaper rash

Net Wt 1 lb (454 g)

INGREDIENTS AND APPEARANCE

LEADER ZINC OXIDE

zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0334
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0334-1	454 g in 1 JAR; Type 0: Not a Combination Product	03/29/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/29/2019

Labeler - Cardinal Health 110,Inc. (063997360)

Revised: 1/2022

Document Id: 6a6c2b6c-078c-4816-a9bc-1e03130793cf

Set id: 4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1

Version: 2

Effective Time: 20220106