FDA Label for Dermarest Eczema Medicated
View Indications, Usage & Precautions
Dermarest Eczema Medicated Product Label
The following document was submitted to the FDA by the labeler of this product Insight Pharmaceuticals 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%
Purpose
Anti-itch
Uses
temporary relief of itching associated with
- minor skin irritations
- inflammation
- rashes due to eczema
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
When Using This Product
do not get into the eyes.
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days
- symptoms 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 (1-800-222-1222) 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 |
Other Information
- shake well
- store at room temperature 15° - 25°C (59°- 77°F)
Inactive Ingredients
Purified water, propylene glycol, glycerin, cetyl alcohol, glyceryl stearate, dimethicone, aleurites moluccana seed oil, zinc PCA, panthenol, carthamus tinctorius (safflower) flower extract, camellia sinensis leaf extract, rheum palmatum root/stalk extract, cyclohexasiloxane, cyclopentasiloxane, xanthan gum, disodium edetate, sodium hydroxide, diazolidinyl urea, methylparaben, propylparaben
Questions?
1-800-344-7239 www.Dermarest.com
Principal Display Panel
Dermarest®
Eczema
Medicated
Lotion
Hydrocortisone 1%
Anti-Itch Lotion
4 FL OZ (118 mL)
* Please review the disclaimer below.