Leader Hydrocortisone With Aloe Cream
FDA Label NDC 70000-0543

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Leader for the product Leader Hydrocortisone With Aloe (NDC 70000-0543). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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)

Principal Display Panel (28 g Tube Carton)

* Please review the disclaimer below.