FDA Label for Absolut Skin Corticosoothe Anti-itch

View Indications, Usage & Precautions

Absolut Skin Corticosoothe Anti-itch Product Label

The following document was submitted to the FDA by the labeler of this product Absolut Skin Incorporated. 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 Ingredients



Hydrocortisone USP I .00%


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, or poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and 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 the treatment of diaper rash. Consult a doctor.

• if you have a vaginal discharge. Consult a doctor.


When Using This Product



• Avoid contact with the eyes. • 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. 


Stop Use And Ask A Doctor If



• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have consulted a doctor.


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. • Children under 2 years of age: Do not use, consult a doctor. • Adults: When practical, cleanse the affected area with mild soap and 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.• Children under 12 years of age: consult a doctor.


Other Information



  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients



Aloe Barbadensis Leaf Juice, Anthemis Nobilis Flower Oil, Behentrimonium Methosulfate, Butyrospermum Parkii(Shea)Butter,Cetearyl Alcohol, Cetyl Alcohol, Cocos Nucifera(Coconut) Oil, Disodium EDTA, Glycerin, Phenoxyethanol, Polysorbate 60, Sodium Hydroxide, Stearic Acid, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Water (Aqua)


Package Labeling:




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