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Natralia Happy Little Bodies Eczema Relief

Dosage form: cream
Ingredients: OATMEAL 50mg in 1g
Labeler: LaCorium Health USA Inc.
NDC Code: 43251-0864

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.

Natralia™ Happy Little Bodies™ Eczema Relief Cream

Drug Facts

Active Ingredient

Colloidal Oatmeal 5%

Purpose

Skin protectant

Uses

Use on affected areas for the symptomatic relief of the below conditions associated with Eczema:

  • Itching
  • Irritation
  • Redness
  • Flaking skin

Warnings
  • For external use only.

Stop use and ask a doctor if
  • Condition worsens
  • Does not improve after regular use (7 days) of this product as directed
  • If local irritation or rash occurs.

When using this product
  • Do not get into eyes
  • If contact occurs, rinse eyes thoroughly with water

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Apply to affected area 3-4 times daily or as needed
  • Smooth in gently
  • Patch test recommended

Other Information

Store between 50°– 86°F in a dry place

Inactive Ingredients

Aloe Vera, Benzyl Alcohol, Calendula Tincture, Castor Oil, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Alcohol, Citric Acid, Dehydroxanthan Gum, Glycerine, Peppermint Oil, Phenoxyethanol, Shea Nut Butter, Sodium Hydroxide, Water, Zinc Oxide

Questions or Comments?

Call Toll Free 1-877-687-2542 usainfo@natralia.com

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

NDC 43251-0864-1

natralia
NATURALLY AUSTRALIAN

happy
little*
bodies™

Eczema
Relief
Cream

SOOTHES RASHES
& FLARE UPS

  • Skin protectant
  • Gentle formula
  • Steroid free

Net Wt 2 oz (56g)

NATRALIA HAPPY LITTLE BODIES ECZEMA RELIEF 
oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43251-0864
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (OATMEAL) OATMEAL50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Aloe Vera Leaf 
PEPPERMINT OIL 
CALENDULA OFFICINALIS FLOWER 
ANHYDROUS CITRIC ACID 
DEHYDROXANTHAN GUM 
Glycerin 
Shea butter 
Cetostearyl alcohol 
Castor oil 
Zinc oxide 
Benzyl alcohol 
CETEARYL GLUCOSIDE 
Phenoxyethanol 
Sodium hydroxide 
Cetyl alcohol 
Packaging
#Item CodePackage Description
1NDC:43251-0864-11 TUBE in 1 CARTON
156 g in 1 TUBE
2NDC:43251-0864-23 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34712/01/2014
Labeler - LaCorium Health USA Inc. (111254392)
Establishment
NameAddressID/FEIOperations
Jalco Pharmaceuticals Pty Ltd757701409MANUFACTURE(43251-0864), PACK(43251-0864), LABEL(43251-0864), ANALYSIS(43251-0864)

Revised: 10/2014
 
LaCorium Health USA Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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