ECODERM - colloidal oatmeal lotion 
Phillips Company

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.

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DRUG FACTS

DRUG FACTS

Drug Facts
Active Ingredient                             Purpose
Colloidal 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.
________________________________________
Warnings
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.
________________________________________
Directions
Apply 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:  hp@valliant.net

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.

Directions
Apply 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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ECODERM 
colloidal oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43074-113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.001 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43074-113-241 in 1 BOX
1NDC:43074-113-233 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/30/2010
Labeler - Phillips Company (612368238)
Establishment
NameAddressID/FEIBusiness Operations
Phillips Company612368238manufacture

Revised: 1/2011
Document Id: 44ab0779-170a-4870-9198-12efcbfdfdd8
Set id: 64c67e81-dbfb-4e8a-b3ae-13ab360673ad
Version: 1
Effective Time: 20110116
 
Phillips Company