FDA Label for Westlake Anti-itch
View Indications, Usage & Precautions
Westlake Anti-itch Product Label
The following document was submitted to the FDA by the labeler of this product Westlake Pharma 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.
Active Ingredient
Hydrocortisone 1 %
Uses
for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
eczema
seborrheic dermatitis
psoriasis
insect bites
poison ivy, poison oak, and poison sumac
cosmetics
jewelry
detergents
soaps
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
When Using This Product
do not get into the eyes
for external anal itching, do not use more than directed unless told to do so by a doctor
do not put into the rectum by using fingers or any mechanical device or applicator
Do Not Use
for the treatment of diaper rash. Ask a doctor.
for external genital itching if you have a vaginal discharge. Ask a doctor.
for external anal itching if rectal bleeding occurs. Consult a doctor promptly.
Stop Us And Ask Doctor If
condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.
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 and over: apply to affected area not more than 3 to 4 times daily
children under 2 years: ask a doctor
for external anal itching in 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 applying.
for external anal itching in children under 12 years: ask a doctor
Other Information
store at 20 °C to 25 °C (68 °F to 77 °F)
Inactive Ingredient
aloe barbadensis (aloe vera) leaf juice, cetearyl alcohol, glycerin, light mineral oil, potassium sorbate, purified water, sodium benzoate, sodium cetearyl sulfate, sodium lauryl sulfate, white petrolatum, white wax
Purpose
Anti-Itch
Content Of Labeling
Hydrocortisone Cream 1% with Aloe Vera
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