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NDC 70000-0543-01 LEADER HYDROCORTISONE WITH ALOE 0.01 g/g Details

LEADER HYDROCORTISONE WITH ALOE 0.01 g/g

LEADER HYDROCORTISONE WITH ALOE is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by LEADER. The primary component is HYDROCORTISONE.

MedlinePlus Drug Summary

Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Related Packages: 70000-0543-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	70000-0543
Product ID	70000-0543_4e79ce8c-37fe-401f-be8f-1d087904f721
Associated GPIs	90559902503720
GCN Sequence Number	016266
GCN Sequence Number Description	hydrocortisone/aloe vera CREAM (G) 1 % TOPICAL
HIC3	Q5P
HIC3 Description	TOPICAL ANTI-INFLAMMATORY STEROIDAL
GCN	92421
HICL Sequence Number	003289
HICL Sequence Number Description	HYDROCORTISONE/ALOE VERA
Brand/Generic	Generic
Proprietary Name	LEADER HYDROCORTISONE WITH ALOE
Proprietary Name Suffix	n/a
Non-Proprietary Name	HYDROCORTISONE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	0.01
Active Ingredient Units	g/g
Substance Name	HYDROCORTISONE
Labeler Name	LEADER
Pharmaceutical Class	Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0543-01 (70000054301)

Pricing Information
NDC Package Code	70000-0543-1
Billing NDC	70000054301
Package	1 TUBE in 1 CARTON (70000-0543-1) / 28 g in 1 TUBE
Marketing Start Date	2020-01-17
NDC Exclude Flag	N
Price Per Unit	0.05643
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	HYDROCORTISONE-ALOE 1% CREAM
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 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 39916470-15bf-4bd0-96e2-b909d68cf9c4 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Antipruritic (anti-itch)

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry
and for external anal and genital itching.

Warnings

For external use only.

Avoid contact with eyes.

Do not use

if you have a vaginal discharge. Consult a doctor.

When using this product

do not exceed the recommended daily dosage unless directed by a doctor
do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or clear up and occurs again within a few days
bleeding occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

For itching associated with minor skin irritations, inflammation, and rashes:

Adults and children 2 years of age and older:

apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a doctor

For external anal and genital itching:

Adults and children 12 years of age and older:

when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: Consult a doctor

Other information

Store at 15 to 30°C (59 to 86°F).

Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions or comments?

866-323-0107 or www.natureplex.com

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

NDC 70000-0543-1

LEADER™

Maximum Strength

Hydrocortisone Cream

with Aloe

Hydrocortisone, 1% | Anti-Itch

COMPARE TO

CORTIZONE-10®

WITH ALOE

MAXIMUM STRENGTH

active ingredient*

100% Money Back Guarantee

Fast Itch Relief

Relief in a Soothing Cream

• Eczema • Insect Bites • Psoriasis

• Poison Ivy, Oak & Sumac • Seborrheic Dermatitis

• Soaps • And More

NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

INGREDIENTS AND APPEARANCE

LEADER HYDROCORTISONE WITH ALOE

hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0543
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	0.01 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE TRISODIUM (UNII: 420IP921MB)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0543-1	1 in 1 CARTON	01/17/2020
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 not final	part348	01/17/2020

Labeler - LEADER (063997360)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex LLC		062808196	MANUFACTURE(70000-0543)

Revised: 6/2021

Document Id: 4e79ce8c-37fe-401f-be8f-1d087904f721

Set id: 39916470-15bf-4bd0-96e2-b909d68cf9c4

Version: 2

Effective Time: 20210621

Search by Drug Name or NDC

NDC 70000-0543-01 LEADER HYDROCORTISONE WITH ALOE 0.01 g/g Details

LEADER HYDROCORTISONE WITH ALOE 0.01 g/g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 70000-0543-01 (70000054301)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 39916470-15bf-4bd0-96e2-b909d68cf9c4 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Do not use

When using this product

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

INGREDIENTS AND APPEARANCE

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