Active Ingredient
Hydrocortisone
Aquanil Hc Lotion
FDA Label NDC 0096-0810
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Person And Covey for the product Aquanil Hc (NDC 0096-0810). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, stop use and ask a doctor, keep out of the reach of children, purpose, directions, inactive ingredients, questions?, uses, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Stop Use And Ask A Doctor
Stop use and ask a doctor if:
-Condition worsens
-If symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
-Do no use for diaper rash. Consult a doctor.
Keep Out Of The Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Purpose
Antipruritic (Anti-itch)
Directions
-Shake well before using.
-For adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily.
-For children under 2 years of age: there is no recommended dosage except under the advice and supervision of a doctor.
-Store away from excessive heat or cold.
Inactive Ingredients
Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Laureth Sulfate, Stearyl Alcohol, Simethicone, Xanthan Gum
Questions?
Questions? Please call (800) 423-2341
Uses
For the temporary relief of minor skin irritations, inflammations, itching and rashes caused by:
-insect bites
-eczema
-psoriasis
-soaps
-detergents
-cosmetics,
-jewelry,
-poison oak,
-poison sumac
-Other uses of this product should be undertaken only under the advice and supervision of a doctor.
Warnings
For external use only.
Do not get into eyes. If contact occurs, rinse thoroughly with water.
* Please review the disclaimer below.
