ATOPIS ECZEMA THERAPY CREAM- colloidal oatmeal cream 
Bionona Limited

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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Colloidal Oatmeal 0.5%

Colloidal Oatmeal 0.5%...... Skin Protectant

temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema • insect bites

For external use only

When using this product
• do not get into 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.

Apply twice daily for best results.

• Safe for the face and body.
• External use only. If irritation should occur discontinue use.
• When using this product you may notice a slight tingling sensation; this is normal and will subside.
• Do not use if quality seal is broken or missing.

Myriphytase extract (Cocos nucifera (coconut) water, Bee pollen, Cocos nucifera coconut) oil, Notofagus fuca honeydew), Cetearyl olivate, Sorbitan olivate, Carthamus tinctorius (Safflower) seed oil, Cetearyl alcohol, Glycerin, Macadamia ternifolia seed oil, Butyrospermum parkii (shea butter), Tocopheryl acetate, Sodium stearoyl glutamate, benzyl alcohol, dehydracetic acid, Citrus aurantium bergamia (bergamot) fruit oil, Xanthan gum, Citric acid.

(855) 969-5002 or contact@atopis.com

ATOPIS

Eczema
Therapy Cream

Skin Protectant


Cream for eczema, rash and insect bite relief

Clinically shown to relieve and protect dry, itchy, irritated skin, due to eczema


• Soothes, nourishes and restores moisture
• No parabens, no solvents, no artificial fragrances
• Clinically trialed on humans, not tested on animals

Product of New Zealand
E Net Wt 2.6 oz/75g

Atopis

ATOPIS ECZEMA THERAPY CREAM 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71570-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COCONUT WATER (UNII: 267F5Y81NT)  
BEE POLLEN (UNII: 3729L8MA2C)  
HONEYDEW MELON (UNII: RN8P45F92A)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCONUT OIL (UNII: Q9L0O73W7L)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
MACADAMIA OIL (UNII: 515610SU8C)  
SHEA BUTTER (UNII: K49155WL9Y)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71570-001-011 in 1 CARTON07/15/2019
175 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/15/2019
Labeler - Bionona Limited (594871226)
Establishment
NameAddressID/FEIBusiness Operations
I. Shay Cosmetics, Inc.151582384manufacture(71570-001)

Revised: 7/2019
Document Id: 8d4b4a14-b632-f2fa-e053-2a95a90a932f
Set id: 8d4b4a14-b631-f2fa-e053-2a95a90a932f
Version: 1
Effective Time: 20190709
 
Bionona Limited