OTC Medication Information: GN Kids Eczema

GN KIDS ECZEMA — oatmeal cream
Grahams Natural Alternatives Pty Ltd

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.

COLLOIDAL OATMEAL

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

Eczema Cream. For external use only.

Eczema cream, apply to affected area.

Topical cream. Apply as needed to affected areas.

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.

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.

GN KIDS ECZEMA oatmeal cream

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (OATMEAL) OATMEAL 25 mg in 1 g

Inactive Ingredients Ingredient Name Strength WATER COCOA BUTTER OLIVE OIL SHEANUT OIL JOJOBA OIL .ALPHA.-TOCOPHEROL, D- VANILLA ALLANTOIN SODIUM BENZOATE POTASSIUM SORBATE CETYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES CETEARYL GLUCOSIDE CETOSTEARYL ALCOHOL LEVOMENOL BETASIZOFIRAN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42387-123-01 1 TUBE (TUBE) in 1 CARTON contains a TUBE (42387-123-00) 1 NDC:42387-123-00 73.7 g in 1 TUBE This package is contained within the CARTON (42387-123-01)

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	Operations
COSMETIC MANUFACTURERS (AUST) PTY. LTD.		758742308	manufacture (42387-123)

Revised: 08/2012 Grahams Natural Alternatives Pty Ltd