Leader™

Leader™
SPL v5
SPL
SPL Set ID 39916470-15bf-4bd0-96e2-b909d68cf9c4
Route
TOPICAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.01 g)
Inactive Ingredients
Aloe Vera Leaf Carbomer Homopolymer, Unspecified Type Cetyl Alcohol Dmdm Hydantoin Glyceryl Monostearate Isopropyl Alcohol Methylparaben Mineral Oil Polysorbate 20 Propylparaben Water Stearic Acid Trolamine Edetate Trisodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-01-17 Until 2027-11-30

Description

Drug Facts

Purpose

Antipruritic (anti-itch)


Medication Information

Purpose

Antipruritic (anti-itch)

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

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

Warnings

For external use only.

Avoid contact with eyes.

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

Do Not Use
  • if you have a vaginal discharge. Consult a doctor.
Active Ingredient

Hydrocortisone 1%

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

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
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)


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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

Purpose

Antipruritic (anti-itch)

Warnings

For external use only.

Avoid contact with eyes.

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

Do Not Use (Do not use)
  • if you have a vaginal discharge. Consult a doctor.
Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (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 (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? (Questions or comments?)

866-323-0107 or www.natureplex.com

When Using This Product (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 (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
Principal Display Panel 28 G Tube Carton (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)


Advanced Ingredient Data


Raw Label Data

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