LEADER HYDROCORTISONE WITH ALOE- hydrocortisone cream

LEADER HYDROCORTISONE WITH ALOE by

Drug Labeling and Warnings

LEADER HYDROCORTISONE WITH ALOE by is a Otc medication manufactured, distributed, or labeled by LEADER, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/17/2020

Labeler - LEADER (097537435)

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