The following Structured Product Label (SPL) was submitted to the FDA by Phillips Company for the product Ecoderm (NDC 43074-113). 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 drug facts, active ingredients, ask doctor, do not use, children, purpose, stop use, when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Drug FactsActive Ingredient PurposeColloidal Oatmeal (0.1%) Skin Protectant Aka Avena sativa (0.1%) Skin Protectant ________________________________________Uses n Temporarily protects and helps relieve minor skin irritation and itching due to eczema.________________________________________Warningsn For external use only n Keep away from children n Avoid contact with eyes n May be harmful if swallowed or inhaled________________________________________Ask a physiciann If symptoms last for more than 7 days or clear up and recur within a few days.n If the conditions do not improve. n Before use on children under 2 years.n Before use if you are allergic to any ingredients listed on this label.________________________________________DirectionsApply to affected skin area and rub gently. Repeat the process as needed.________________________________________Other information This is an OTC skin protectant drug product for human use. Store at 40 to 100 degrees F. Net contents: 3 mL (dropper bottle). This product contains no alcohol; no animal products. ________________________________________Inactive ingredients Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid. ________________________________________Questions and Side effects Use of this product results in no known side effects when used according to directions. Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750; Tel. 580-746-2430 Email address:
[email protected]Active Ingredients
Colloidal Oatmeal (0.1%) Skin Protectant
Aka Avena sativa (0.1%) Skin Protectant
Ask Doctor
Ask a doctor
n If symptoms last for more than 7 days or clear up and recur within a few days.
n If the conditions do not improve.
n Before use on children under 2 years.
n Before use if you are allergic to any ingredients listed on this label.
Do Not Use
N Avoid contact with eyes
n May be harmful if swallowed or inhaled
Children
Keep away from children
Avoid contact with eyes
May be harmful if swallowed or inhaled
Purpose
N Temporarily protects and helps relieve minor skin irritation and itching due to eczema.
Stop Use
N For external use only
n Keep away from children
n Avoid contact with eyes
n May be harmful if swallowed or inhaled
________________________________________
Ask a physician
n If symptoms last for more than 7 days or clear up and recur within a few days.
n If the conditions do not improve.
n Before use on children under 2 years.
n Before use if you are allergic to any ingredients listed on this label.
When Using
Apply to affected skin area and rub gently. Repeat the process as needed.Store at 40 to 100 degrees F.
n Temporarily protects and helps relieve minor skin irritation and itching due to eczema.n For external use only
n Keep away from children
n Avoid contact with eyes
n May be harmful if swallowed or inhaled
Ask a physician If symptoms last for more than 7 days or clear up and recur within a few days.
Warnings
N For external use only n Keep away from children n Avoid contact with eyes n May be harmful if swallowed or inhaled
Dosage & Administration
Apply to affected skin area and rub gently. Repeat the process as needed.
Use
Uses n Temporarily protects and helps relieve minor skin irritation and itching due to eczema.DirectionsApply to affected skin area and rub gently. Repeat the process as needed.
Inactive Ingredients
Inactive ingredients Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid.
Image Of Product
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