NATRALIA ECZEMA AND PSORIASIS- sodium borate, graphite, potassium sulfate, and sodium chloride cream

natralia by

Drug Labeling and Warnings

natralia by is a Homeopathic medication manufactured, distributed, or labeled by LaCorium Health USA Inc., Ross Cosmetics Australia Pty. Ltd., Denison Pharmaceuticals LLC, ALS Laboratory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
* The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. † The letters E & P R indicate Eczema & Psoriasis Relief.
Borax (20 X H.P.U.S.0.2%)*	†E & P R
Graphites (6 X H.P.U.S.0.2%)*	†E & P R
Kalium Sulphuricum (3 X H.P.U.S. 0.2%)*	†E & P R
Natrum Muriaticum (12 X H.P.U.S. 0.2%)*	†E & P R

Uses

Use on affected areas for relief of itching, irritation, redness, flaking and scaling associated with Eczema & Psoriasis.

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.
• Do not use on broken skin.

Keep out of the reach of children.

Directions

• Apply to affected skin 2-3 times daily
• Smooth in gently
• The smallest effective dose should be used
• Patch test recommended on sensitive skin
• Suitable for use on children 2 years of age and older

Other Information

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

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Anthemis Nobilis (Chamomile) Oil, Butyrospermum Parkii (Shea) Butter, Capric/Caprylic Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Ceteareth-20, Glycyrrhiza Glabra (Licorice) Root Extract, Lavandula Angustifolia (Lavender) Oil, Oenothera Biennis (Evening Primrose) Oil, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Sorbic Acid, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water, Zinc Oxide

Questions or Comments?

Call Toll Free 1-877-687-2542

usainfo@natralia.com

www.natralia.com

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

NDC: 43251-2241-1

natralia™
NATURALLY AUSTRALIAN

Eczema &
Psoriasis
Cream

RASH RELIEF

BEFORE

AFTER

• Relieves rash,
  irritation, itching
  and redness
• Free from
  cortisone, coal
  and pine tar

Proud Supporter
eczema
association
australasia
eaa

SUITABLE FOR CHILDREN

Homeopathic

Net Wt 2 oz (56g)

INGREDIENTS AND APPEARANCE

NATRALIA   ECZEMA AND PSORIASIS
sodium borate, graphite, potassium sulfate, and sodium chloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43251-2241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Borate (UNII: 91MBZ8H3QO) (Borate ion - UNII:44OAE30D22)	Sodium Borate	20 [hp_X]  in 1 g
Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O)	Graphite	6 [hp_X]  in 1 g
Potassium Sulfate (UNII: 1K573LC5TV) (SULFATE ION - UNII:7IS9N8KPMG)	Potassium Sulfate	3 [hp_X]  in 1 g
Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37)	Sodium Chloride	12 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Zinc Oxide (UNII: SOI2LOH54Z)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
Glycyrrhiza Glabra (UNII: 2788Z9758H)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Avocado Oil (UNII: 6VNO72PFC1)
Cocoa Butter (UNII: 512OYT1CRR)
Shea Butter (UNII: K49155WL9Y)
Caprylyl Glycol (UNII: 00YIU5438U)
Sorbic Acid (UNII: X045WJ989B)
Phenoxyethanol (UNII: HIE492ZZ3T)
Chamaemelum Nobile Flower Oil (UNII: UB27587839)
Evening Primrose Oil (UNII: 3Q9L08K71N)
Aloe Vera Leaf (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43251-2241-1	1 in 1 CARTON	03/01/2009
1		56 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 43251-2241-2	1 g in 1 PACKET; Type 0: Not a Combination Product	03/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		03/01/2009

Labeler - LaCorium Health USA Inc. (111254392)

Establishment
Name	Address	ID/FEI	Business Operations
Ross Cosmetics Australia Pty. Ltd.		753529114	MANUFACTURE(43251-2241) , PACK(43251-2241) , ANALYSIS(43251-2241)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals LLC		001207208	MANUFACTURE(43251-2241) , PACK(43251-2241) , ANALYSIS(43251-2241) , LABEL(43251-2241)

Establishment
Name	Address	ID/FEI	Business Operations
ALS Laboratory		758817084	ANALYSIS(43251-2241)