PURE BIOLOGY ECZEMA WITH COLLOIDAL OATMEAL- oatmeal cream 
Pure Biology Products LLC

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PURE BIOLOGY Eczema Cream with Colloidal Oatmeal

Drug Facts:

Active Ingredient

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Indications:

Temporarily protects and helps relieve minor skin irritation and itching to due to Eczema or rashes.

Warnings:

  • For external use only.
  • Avoid contact with eyes.

Stop use and ask a doctor if:

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

Keep out of reach of children.

  • If swallowed, consult physician.

Directions:

  • Adults and children two-years of age or older: Apply as needed
  • Children under two-years of age: consult a physician.

Additional Information:

for use on mild to moderate Eczema or as directed by physician. Store at room temperature.

Other Ingredients:

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Cannabis Sativa (Organic Hemp) Seed Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Extract, Emu Oil, Emulsifying Wax NF, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), Phenoxyethanol, Punica Granatum (Pomegranate) Extract, Xanthan Gum.

Package Labeling:

Label2

PURE BIOLOGY ECZEMA WITH COLLOIDAL OATMEAL 
oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79217-158
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SAFFLOWER (UNII: 4VBL71TY4Y)  
CHAMOMILE (UNII: FGL3685T2X)  
CUCUMBER (UNII: YY7C30VXJT)  
EMU OIL (UNII: 344821WD61)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POMEGRANATE (UNII: 56687D1Z4D)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79217-158-01115 mL in 1 JAR; Type 0: Not a Combination Product06/14/202009/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01606/14/202009/30/2022
Labeler - Pure Biology Products LLC (072418922)

Revised: 10/2023
 
Pure Biology Products LLC