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.

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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

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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