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

Natralia Eczema and Psoriasis by

Drug Labeling and Warnings

Natralia Eczema and Psoriasis by is a Homeopathic medication manufactured, distributed, or labeled by LaCorium Health USA Inc., Denison Pharmaceuticals LLC, Ross Cosmetics Aust Pty Ltd. 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.
Borax (20 X H.P.U.S. 0.2%)*	Eczema & Psoriasis Relief
Graphites (6 X H.P.U.S. 0.2%)*	Eczema & Psoriasis Relief
Kalium Sulphuricum (3 X H.P.U.S.0.2%)*	Eczema & Psoriasis Relief
Natrum Muriaticum (12 X H.P.U.S.0.2%)*	Eczema & Psoriasis Relief

Uses

• Use on affected areas in place of your regular soap and shampoo for relief of itching, irritation, redness, flaking and scaling associated with eczema and 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

• Use in place of soap to cleanse and soothe the skin
• Rinse off with plenty of water
• The smallest effective dose should be used
• Avoid very hot water

Other Information

Store between 50°- 86°F.

Inactive ingredients

Aloe Vera, Bergamot Oil, Calendula Officinalis, Citric Acid, Cocamidopropyl Betaine, Decyl Glucoside, Diazolidinylurea, Lauryl Glucoside, Lavandula Angustifolia, Matricaria Chamomilla, PEG-120 Methyl Glucose Dioleate, Phenoxyethanol, Sodium Cocoamphoacetate, Sodium Lauroyl Sarcosinate, Water

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

NDC: 43251-2281-1

natralia™
NATURALLY AUSTRALIAN

Eczema &
Psoriasis Wash
& Shampoo

SOAP FREE

• Relieves skin
  irritation, itching,
  flaking and
  dryness
• 2-in-1 body
  wash and
  shampoo

Proud Supporter
eczema
association
australasia
eaa

SUITABLE FOR CHILDREN

Homeopathic

Net Wt 7 oz (200 mL)

383FL-8

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43251-2281
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 mL
Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O)	Graphite	6 [hp_X]  in 1 mL
Potassium Sulfate (UNII: 1K573LC5TV) (Sulfate Ion - UNII:7IS9N8KPMG)	Potassium Sulfate	3 [hp_X]  in 1 mL
Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37)	Sodium Chloride	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Lauryl glucoside (UNII: 76LN7P7UCU)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
Chamomile (UNII: FGL3685T2X)
Lavender Oil (UNII: ZBP1YXW0H8)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Diazolidinyl urea (UNII: H5RIZ3MPW4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Lauroyl Sarcosinate (UNII: 632GS99618)
Decyl glucoside (UNII: Z17H97EA6Y)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
PEG-120 Methyl glucose dioleate (UNII: YM0K64F20V)
Citric acid monohydrate (UNII: 2968PHW8QP)
Bergamot Oil (UNII: 39W1PKE3JI)
Sodium Cocoamphoacetate (UNII: W7Q5E87674)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43251-2281-1	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		01/03/2009

Labeler - LaCorium Health USA Inc. (111254392)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals LLC		001207208	MANUFACTURE(43251-2281) , PACK(43251-2281) , LABEL(43251-2281) , ANALYSIS(43251-2281)

Establishment
Name	Address	ID/FEI	Business Operations
Australian Laboratory Services		758817084	ANALYSIS(43251-2281)

Establishment
Name	Address	ID/FEI	Business Operations
Ross Cosmetics Aust Pty Ltd		753529114	MANUFACTURE(43251-2281) , PACK(43251-2281) , LABEL(43251-2281) , ANALYSIS(43251-2281)