FDA Label for Hydrocortisone With Aloe

View Indications, Usage & Precautions

Hydrocortisone With Aloe Product Label

The following document was submitted to the FDA by the labeler of this product Encube Ethicals, Inc.. 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(S)



Hydrocortisone USP, 1%


Purpose



Anti-itch


Use(S)



■ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to

    ■ eczema ■ psoriasis ■ insect bites ■ poison ivy, oak sumac

    ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis

■ temporarily relieves external anal and genital 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



■ in the genital area if you have a vaginal discharge. Consult a doctor.

■ for the treatment of diaper rash. Consult a doctor.


When Using This Product



■ avoid contact with the eyes

■ do not use more than directed unless directed by a doctor

■ do not put directly into the rectum by using fingers or any mechanical device or applicator 


Stop Use And Ask Doctor If



■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days

■ do not begin the use of any ether hydrocortisone product unless directed by a doctor

■ rectal bleeding occurs


Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center {1-800-222-1222) right away.


Directions



■ for itching of skin irritation, 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 genial 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

■ 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°C to 30°C (59°F to 86°F). Protect from freezing.

■ before using any medication, read all label directions. Keep carton, it contains important information.


Inactive Ingredient



aloe vera concentrate, cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, methyl paraben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, solution*, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax


*Contains one or more of these ingredients to adjust pH


Questions?



Call 1-833-285-4151


Principal Display Panel



Hydrocortisone Cream USP, 1% with Aloe

Anti-itch Cream

Net wt. 1 oz (28g)

  

Hydrocortisone Cream USP, 1% with Aloe

Anti-itch Cream

Net wt. 0.5 oz (14g)


* Please review the disclaimer below.