Label: ECODERM- colloidal oatmeal lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 43074-113-23, 43074-113-24 - Packager: Phillips Company
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 16, 2011
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DRUG FACTS
Drug Facts
Active Ingredient Purpose
Colloidal Oatmeal (0.1%) Skin Protectant
Aka Avena sativa (0.1%) Skin Protectant
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Uses
n Temporarily protects and helps relieve minor skin irritation and itching due to eczema.
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Warnings
n For external use only
n Keep away from children
n Avoid contact with eyes
n May be harmful if swallowed or inhaled
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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.
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Directions
Apply to affected skin area and rub gently. Repeat the process as needed.
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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.
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Inactive ingredients
Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid.
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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: hp@valliant.net
- ACTIVE INGREDIENTS
- ASK DOCTOR
- DO NOT USE
- CHILDREN
- PURPOSE
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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.
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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
- DOSAGE & ADMINISTRATION
- USE
- INACTIVE INGREDIENTS
- Image of product
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INGREDIENTS AND APPEARANCE
ECODERM
colloidal oatmeal lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43074-113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 0.001 mL in 1 mL Inactive Ingredients Ingredient Name Strength dimethyl sulfoxide (UNII: YOW8V9698H) ascorbic acid (UNII: PQ6CK8PD0R) dipropylene glycol (UNII: E107L85C40) water (UNII: 059QF0KO0R) sorbic acid (UNII: X045WJ989B) magnesium stearate (UNII: 70097M6I30) stearic acid (UNII: 4ELV7Z65AP) sodium dodecylbenzenesulfonate (UNII: 554127163Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43074-113-24 1 in 1 BOX 1 NDC:43074-113-23 3 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/30/2010 Labeler - Phillips Company (612368238) Establishment Name Address ID/FEI Business Operations Phillips Company 612368238 manufacture