NATRALIA ECZEMA MOISTURIZING- oatmeal lotion

Natralia Eczema Moisturizing by

Drug Labeling and Warnings

Natralia Eczema Moisturizing by is a Otc medication manufactured, distributed, or labeled by LaCorium Health USA Inc., Ross Cosmetics Aust Pty Ltd, Scental Pacific Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Colloidal Oatmeal 2%

Purpose

Skin protectant

Uses

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

• Eczema
• Rashes

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

Water, Medium Chain Triglycerides, Glycerine, Cetearyl Alcohol, Glyceryl Distearate, Glyceryl Monostearate, Glyceryl Stearate Citrate, Benzyl Alcohol, Phenoxyethanol, Ethylhexylglycerin, Cera Alba, Simmondsia Chinensis (Jojoba) Seed Oil, Magnesium Aluminium Silicate, Sodium Hydroxide, Xanthan Gum

Questions or Comments?

Call Toll Free 1-877-687-2542

usainfo@natralia.com

www.natralia.com

PRINCIPAL DISPLAY PANEL - 175 ml Tube Carton

NDC: 43251-0857-1

natralia™
NATURALLY AUSTRALIAN

Eczema
Moisturizing
Lotion

FOR DAILY USE

Protects skin from
irritation and itching

Relieves
dry skin

With
Colloidal
Oatmeal

24 HOUR
MOISTURE LOCK

CORTISONE FREE

Net contents 6 fl oz (175 ml)

INGREDIENTS AND APPEARANCE

NATRALIA ECZEMA MOISTURIZING 
oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43251-0857
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Xanthan gum (UNII: TTV12P4NEE)
Glycerin (UNII: PDC6A3C0OX)
Magnesium aluminum Silicate (UNII: 6M3P64V0NC)
Jojoba oil (UNII: 724GKU717M)
White wax (UNII: 7G1J5DA97F)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Benzyl alcohol (UNII: LKG8494WBH)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)
Sodium hydroxide (UNII: 55X04QC32I)
Cetostearyl alcohol (UNII: 2DMT128M1S)
Glyceryl Stearate Citrate (UNII: WH8T92A065)
Glyceryl distearate (UNII: 73071MW2KM)
Medium-chain triglycerides (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43251-0857-1	1 in 1 CARTON	12/01/2014
1		175 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 43251-0857-2	3 mL 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 Aust Pty Ltd		753529114	MANUFACTURE(43251-0857) , PACK(43251-0857) , LABEL(43251-0857) , ANALYSIS(43251-0857)

Establishment
Name	Address	ID/FEI	Business Operations
Scental Pacific Pty Ltd		744482427	MANUFACTURE(43251-0857) , PACK(43251-0857) , LABEL(43251-0857) , ANALYSIS(43251-0857)