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.

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DRUG FACTS

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.

image of box image of box

GN KIDS ECZEMA  
oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42387-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42387-123-011 in 1 CARTON
1NDC:42387-123-0073.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/24/2012
Labeler - Grahams Natural Alternatives Pty Ltd (742235419)
Registrant - COSMETIC MANUFACTURERS (AUST) PTY. LTD. (758742308)
Establishment
NameAddressID/FEIBusiness Operations
COSMETIC MANUFACTURERS (AUST) PTY. LTD.758742308manufacture(42387-123)

Revised: 8/2012
Document Id: 9115b517-7163-4b7a-b471-94890e82ec4c
Set id: a12761e4-46c0-4eea-b5f3-ceccaea7efa3
Version: 8
Effective Time: 20120813
 
Grahams Natural Alternatives Pty Ltd