NATRALIA HAPPY LITTLE BODIES ECZEMA RELIEF- oatmeal cream

Natralia Happy Little Bodies Eczema Relief by

Drug Labeling and Warnings

Natralia Happy Little Bodies Eczema Relief by is a Otc medication manufactured, distributed, or labeled by LaCorium Health USA Inc., Ross cosmetics Pty ltd, Australian Laboratory Services Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Colloidal Oatmeal 5%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to:

• rashes
• eczema
• poison ivy, oak, or sumac
• insect bites

Warnings

For external use only.

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days.

When using this product

• do not get into eyes
• If contact occurs, rinse eyes thoroughly with water. Apply a small amount to healthy skin
• wait 15 minutes. If redness or swelling occurs, discontinue use.
• Do not use on broken skin.

If pregnant or breastfeeding, ask a healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply as needed
• Smooth in gently

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

NEW
LOOK!
Same gentle formula

NDC: 43251-0864-1

natralia™
NATURALLY AUSTRALIAN

happy
little
bodies™

ECZEMA
RELIEF
CREAM

SOOTHES
RASHES &
FLARE UPS

SKIN PROTECTANT
GENTLE FORMULA
CORTISONE FREE

Net Wt
2 oz (56g)

INGREDIENTS AND APPEARANCE

NATRALIA HAPPY LITTLE BODIES ECZEMA RELIEF 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43251-0864
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
PEPPERMINT OIL (UNII: AV092KU4JH)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
Glycerin (UNII: PDC6A3C0OX)
Shea butter (UNII: K49155WL9Y)
Cetostearyl alcohol (UNII: 2DMT128M1S)
Castor oil (UNII: D5340Y2I9G)
Zinc oxide (UNII: SOI2LOH54Z)
Benzyl alcohol (UNII: LKG8494WBH)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium hydroxide (UNII: 55X04QC32I)
Cetyl alcohol (UNII: 936JST6JCN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43251-0864-1	1 in 1 CARTON	12/01/2014
1		56 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 43251-0864-2	3 g in 1 PACKET; Type 0: Not a Combination Product	12/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/01/2014

Labeler - LaCorium Health USA Inc. (111254392)

Establishment
Name	Address	ID/FEI	Business Operations
Ross cosmetics Pty ltd		753529114	MANUFACTURE(43251-0864) , PACK(43251-0864) , LABEL(43251-0864) , ANALYSIS(43251-0864)

Establishment
Name	Address	ID/FEI	Business Operations
Australian Laboratory Services Pty Ltd		758817084	ANALYSIS(43251-0864)