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Eczema Plus Kids Soothing Body Cream

Dosage form: cream
Ingredients: OATMEAL 1mg in 1mg
Labeler: Skinfix, Inc.
NDC Code: 61328-111

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.

Active Ingredients

Colloidal Oatmeal 1%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritations and itching due to eczema, rash and dermatitis.

Warnings

For external use only

When using this product

  • Avoid contact with eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply generously to affected areas, especially after bathing.

Other information

Store at 65-75°F. May stain fabrics.

For adults and children two years of age and older.

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Kernel Extract, Avena Sativa (Oat) Kernel Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl-Caprylate/Caprate, Citric Acid, Cocos Nucifera (Coconut) Oil, Ethyhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Oil, Oryza Sativa (Rice) Bran Exract, Phenoxyethanol, Polyglyceryl-2 Stearate, Potassium Sorbate,Prunus Amygdalus Dulcis (Sweet Almond) Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Stearyl Alcohol, Tocopherol, Trisodium Ethylenediamine Disuccinate, Vitis Vinifera (Grape) Seed Oil, Water (Aqua/Eau), Xanthan Gum.

ECZEMA PLUS KIDS SOOTHING BODY CREAM 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-111
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (OATMEAL) OATMEAL1 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
ALOE VERA LEAF 
OAT 
OAT KERNEL OIL 
SHEA BUTTER 
MEDIUM-CHAIN TRIGLYCERIDES 
CAPRYLYL CAPRYLATE/CAPRATE 
CITRIC ACID MONOHYDRATE 
COCONUT OIL 
ETHYLHEXYLGLYCERIN 
GLYCERIN 
GLYCERYL MONOSTEARATE 
HELIANTHUS ANNUUS FLOWERING TOP 
SUNFLOWER OIL 
RICE BRAN 
PHENOXYETHANOL 
POLYGLYCERYL-2 MONOISOSTEARATE 
POTASSIUM SORBATE 
ALMOND OIL 
ROSEMARY 
JOJOBA OIL 
STEARYL ALCOHOL 
TOCOPHEROL 
TRISODIUM ETHYLENEDIAMINE DISUCCINATE 
GRAPE SEED OIL 
WATER 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:61328-111-14177 mg in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/14/2016
Labeler - Skinfix, Inc. (203158183)
Registrant - Skinfix, Inc. (203158183)

Revised: 11/2016
 
Skinfix, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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