FDA Label for Hydroskin
View Indications, Usage & Precautions
Hydroskin Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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%
Purpose
Anti-itch
Uses
- for temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- psoriasis
- poison ivy, oak, sumac
- cosmetics
- insect bites
- detergents
- jewelry
- seborrheic dermatitis
- soaps
- 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
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.
When Using This Product
- avoid contact with the eyes
- do not begin use of any other hydrocortisone product unless you have asked a doctor
- for external anal itching 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
- symptoms persist for more than 7 days or clear up and occur again within a few days. 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
shake well before use
adults and children 2 years of age and older:
- apply to affected area not more than 3 to 4 times daily
- Ask a doctor.
- adults: 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 application of this product.
- children under 12 years of age with external anal itching: ask a doctor
children under 2 years of age:
for external anal itching:
Inactive Ingredients
benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate, isopropyl palmitate, lactic acid, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, sorbitol solution 70%, stearyl alcohol, white wax.
Questions Or Comments?
1-800-645-2158
Package/Label Principal Display Panel
Rugby Laboratories
Maximum Strength
HydroSKIN
hydrocortisone 1% Lotion
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