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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71570-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71570-001-01	1 in 1 CARTON	07/15/2019
1		75 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	07/15/2019

Labeler - Bionona Limited (594871226)

Name	Address	ID/FEI	Business Operations
Establishment
I. Shay Cosmetics, Inc.		151582384	manufacture(71570-001)