Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 64c67e81-dbfb-4e8a-b3ae-13ab360673ad
Route
TOPICAL
Published
Effective Date 2011-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (0.001 mL)
Inactive Ingredients
Dimethyl Sulfoxide Ascorbic Acid Dipropylene Glycol Water Sorbic Acid Magnesium Stearate Stearic Acid Sodium Dodecylbenzenesulfonate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-12-30

Description

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:  [email protected]

Purpose

n Temporarily protects and helps relieve minor skin irritation and itching due to eczema.


Medication Information

Purpose


n Temporarily protects and helps relieve minor skin irritation and itching due to eczema.

Description

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:  [email protected]

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.



Children

 

Keep away from children   

Avoid contact with eyes  

May be harmful if swallowed or inhaled

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.

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 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

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:  [email protected]

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.



Image of Product
Image of product





Active Ingredients
Colloidal Oatmeal (0.1%)                 Skin Protectant

Aka Avena sativa (0.1%)                 Skin Protectant

Inactive Ingredients
Inactive ingredients  

Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid. 

Dosage & Administration
Apply to affected skin area and rub gently.  Repeat the process as needed.




Structured Label Content

Use (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.



Purpose (PURPOSE)


n Temporarily protects and helps relieve minor skin irritation and itching due to eczema.

Children (CHILDREN)

 

Keep away from children   

Avoid contact with eyes  

May be harmful if swallowed or inhaled

Stop Use (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.

Warnings (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 Doctor (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 (DO NOT USE)
n Avoid contact with eyes  

n May be harmful if swallowed or inhaled

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:  [email protected]

When Using (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.



Image of Product (Image of product)
Image of product





Active Ingredients (ACTIVE INGREDIENTS)
Colloidal Oatmeal (0.1%)                 Skin Protectant

Aka Avena sativa (0.1%)                 Skin Protectant

Inactive Ingredients (INACTIVE INGREDIENTS)
Inactive ingredients  

Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid. 

Dosage & Administration (DOSAGE & ADMINISTRATION)
Apply to affected skin area and rub gently.  Repeat the process as needed.




Advanced Ingredient Data


Raw Label Data

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