FDA Label for Hydrocortisone Maximum Strength With Aloe
View Indications, Usage & Precautions
Hydrocortisone Maximum Strength With Aloe Product Label
The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Hydrocortisone, USP 1%
Purpose
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• jewelry• detergents• cosmetics• psoriasis• seborrheic dermatitis• for external genital, feminine and anal itching• other uses of this product should be only under the advice and supervision of a doctor
Warnings
For external use only
Do Not Use
• for external feminine itching if you have a vaginal discharge. Consult a doctor.• for the treatment of diaper rash. Consult a doctor.
When Using This Product
o do not use more than directed unless directed by a doctor
o do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
• symptoms last for more than 7 days• the condition gets worse• symptoms clear up and occur again in a few days• rectal bleeding occurs, consult doctor promptly
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 2 years of age and older
• apply to affected area not more than 3 to 4 times daily• do not use, consult a doctor
Children under 2 years of age
For external anal itching
Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Children under 12 years of age: consult a doctor
Other Information
• Store at room temperature 59°-86°F (15°-30°C). Protect from freezing.• Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients
aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax. May contain citric acid or sodium citrate solution to adjust pH.
Questions?
1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.
Principal Display Panel
MAJOR®
Maximum Strength
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
NDC 63187-567-01
Hydrocortisone ● 10
Hydrocortisone Cream, USP 1%
antipruritic (anti-itch) cream with Aloe
NET WT 1 OZ (28 g)
Compare to the Active ingredient in Cortizone • 10®*
Temporary Relief of Itching and Rashes Due to:
· Insect Bites
· Eczema
· Soaps
· Poison Ivy, Oak, Sumac
· Seborrheic Dermatitis
· Cosmetics
· Psoriasis
· Jewelry
· Detergents
03390311B1 VC110479 Rev 06/11
* Please review the disclaimer below.