FDA Label for Hydrocortisone 1% With Healing Aloe

View Indications, Usage & Precautions

Hydrocortisone 1% With Healing Aloe Product Label

The following document was submitted to the FDA by the labeler of this product Trifecta Pharmaceuticals Usa Llc. 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.

Drug Facts




Active Ingredient



Hydrocortisone 1%


Purpose



Anti-Itch


Uses



temporary relieves itching associated with minor skin irritations, inflammation and rashes due to:

● eczema        ● seborrheic dermatitis      ● psoriasis     ● insect bites    ● poison ivy, oak, sumac      ● soaps    

● detergents   ● cosmetics                        ● jewelry        ● external genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor


Warnings



●for external use only ● avoid contact with the eyes

●do not put this product into the rectum by using fingers or any mechanical device or applicator

● Stop using this product and ask a doctor ● in case of bleeding

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

● before you begin using any other hydrocortisone product

Do not use this product and ask a doctor

● if you have a vaginal discharge ● before treating diaper rash ● before using on children under 2 years of age

For External Anal Itching Users: ● do not exceed the recommended daily dosage unless directed by a doctor

● in case of bleeding, consult a doctor promptly

● do not put this product into the rectum by using fingers or any mechanical device or applicator

● children under 12 years of age: consult a doctor

Before using any medication, read all label directions. Keep this carton. It contains important information.


Directions



●when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.

●gently dry by patting or blotting with toilet tissue or a soft cloth before applying.

●adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.

●children under 12 years of age: do not use, consult a doctor.


Inactive Ingredients



Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecanol, petrolatum, purified water, sodium dodecyl sulfate


Other Information



● to open: unscrew cap and pull tab to remove foil seal

● if seal has been broken, do not use this product. Return product to the Store where you bought it

● store at controlled room temperature 15°-30°C ( 59 °- 86 °F)

see carton or tube crimp for lot number and expiration date


* Please review the disclaimer below.