GN KIDS ECZEMA- oatmeal cream

GN Kids Eczema by

Drug Labeling and Warnings

GN Kids Eczema by is a Otc medication manufactured, distributed, or labeled by Grahams Natural Alternatives Pty Ltd, COSMETIC MANUFACTURERS (AUST) PTY. LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

COLLOIDAL OATMEAL

KEEP OUT OF REACH OF CHILDREN

Keep Out Of Reach Of Children.
If swallowed,get medical help or contact a Poison Control Center immediately.

PURPOSE

Eczema Cream. For external use only.

INDICATIONS & USAGE

Eczema cream, apply to affected area.

DOSAGE & ADMINISTRATION

Topical cream. Apply as needed to affected areas.

WARNINGS

For External use only. When using this product do not get into eyes.

If pregnant or breastfeeding, ask a professional before use.

Stop use and ask doctor if conditions worsen, symptoms last more than 7days or clear up and occur again in a few days.

INACTIVE INGREDIENT

Water,Theobroma Oil, Olea Europaea Fruit Oil, Vitellaria Paradoxa, Simmondsia Chimensis Seed Oil, D-Alpha Tocopheryl Acetate,Vanilla Planifolia tincture, Allantoin, Sodium Benzoate, Potassium Sorbate, Cetyl Alcohol, Capryllic/Capric Triglyceride,Cetearyl Glucoside, Cetostearyl Alcohol, Bisabolol, Sclerotium Gum.

PRINCIPAL DISPLAY PANEL

image of box

INGREDIENTS AND APPEARANCE

GN KIDS ECZEMA  
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42387-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCOA BUTTER (UNII: 512OYT1CRR)
OLIVE OIL (UNII: 6UYK2W1W1E)
SHEANUT OIL (UNII: O88E196QRF)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
VANILLA (UNII: Q74T35078H)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CETYL ALCOHOL (UNII: 936JST6JCN)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LEVOMENOL (UNII: 24WE03BX2T)
BETASIZOFIRAN (UNII: 2X51AD1X3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42387-123-01	1 in 1 CARTON
1	NDC: 42387-123-00	73.7 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/24/2012

Labeler - Grahams Natural Alternatives Pty Ltd (742235419)

Registrant - COSMETIC MANUFACTURERS (AUST) PTY. LTD. (758742308)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIC MANUFACTURERS (AUST) PTY. LTD.		758742308	manufacture(42387-123)