ATOPIS ECZEMA THERAPY CREAM- colloidal oatmeal cream

Atopis Eczema Therapy Cream by

Drug Labeling and Warnings

Atopis Eczema Therapy Cream by is a Otc medication manufactured, distributed, or labeled by Bionona Limited, I. Shay Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Colloidal Oatmeal 0.5%

PURPOSE

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

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

Apply twice daily for best results.

STORAGE AND HANDLING

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.

INACTIVE INGREDIENT

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.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

ATOPIS ECZEMA THERAPY CREAM 
colloidal oatmeal cream

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

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/15/2019

Labeler - Bionona Limited (594871226)

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