LEADER HYDROCORTISONE WITH ALOE: Package Insert and Label Information
LEADER HYDROCORTISONE WITH ALOE- hydrocortisone cream
LEADER
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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
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)
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| Labeler — LEADER (063997360) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Natureplex LLC | 062808196 | MANUFACTURE (70000-0543) | |
Revised: 06/2021 LEADER
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