FDA Label for Hydrocortisone

View Indications, Usage & Precautions

Hydrocortisone 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.
■ tor the treatment o1 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  isopropyl 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 other 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 yearn of age and older: apply to affected area not more than 3 to 4 times daily

■ children under 2 yearn of age: consult a doctor

■ for external anal and genital itching

■ adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly

■ gently dry by paling or blotting with toilet Issue or a soft cloth before application of this product

■ apply to affected area not more than 3 to 4 times daily 

■ children under 12 yearn of age: consult a doctor


Other Information



■ store at 15°C to 30°C (59°F to 86°8). Protect from freezing.

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


Inactive Ingredients



cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, methylparaben, 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 Or Comments?



Call 1-833-285-4151


Principal Display Panel



Hydrocortisone Cream USP, 1%

Anti-itch Cream

Net wt. 1 oz (28g)

  

Hydrocortisone Cream USP, 1%

Anti-itch Cream

Net wt. 0.5 oz (14g)


* Please review the disclaimer below.