NATRALIA ANTI-ITCH SOOTHING- oatmeal and menthol cream

Natralia Anti-Itch Soothing by

Drug Labeling and Warnings

Natralia Anti-Itch Soothing by is a Otc medication manufactured, distributed, or labeled by LaCorium Health USA Inc, Scental Pacific Pty Ltd, Australian Laboratory Services Pty Ltd . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Colloidal Oatmeal 2%	Skin protectant
Menthol 0.6%	Topical analgesic

Uses

For temporary relief of pain and itching associated with minor skin irritation, cuts or scrapes and sunburn. Temporarily protects and helps relieve itching and minor skin irritations caused by:

• Rashes
• Eczema
• Poison Ivy, Oak or Sumac
• Insect Bites

Warnings

For external use only

Do not use on open wounds or broken skin

Stop use and ask a doctor if condition worsens or does not improve after regular use (7 days) of this product as directed or if local irritation or rash occurs

Avoid contact with 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

• Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily. Children under 2 years of age: consult a doctor.
• Smooth in gently
• Patch test recommended on sensitive skin

Other Information

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

Inactive Ingredients

Benzyl Alcohol, Butyrospermum Parkii (Shea Butter), Cetyl Alcohol, Dimethicone, Disodium EDTA, Distearyldimonium Chloride, Epilobium Angustifolium Flower/Leaf/Stem Extract, Glyceryl Stearate (and) PEG-100 Stearate, Hydroxyethyl Cellulose, Isopropyl Palmitate, Jojoba Esters, Phenoxyethanol, Sodium Hydroxide, Sodium Metabisulfite, Stearyl Alcohol (and) Ceteareth-20, Theobrome Cacao (Cocoa) Seed Butter, Water

Questions or Comments?

Call Toll Free 1-877-687-2542

usainfo@natralia.com

www.natralia.com

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

NDC: 43251-3345-1

natralia™
NATURALLY AUSTRALIAN

Anti-Itch
Soothing
Cream

SOOTHES & RELIEVES IRRITATED SKIN

• Topical analgesic
  & skin protectant
• With colloidal
  oatmeal
  & menthol

CORTISONE
FREE

FAST ACTING

Net wt 3 oz (85g)

INGREDIENTS AND APPEARANCE

NATRALIA ANTI-ITCH SOOTHING 
oatmeal and menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43251-3345
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 g
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Isopropyl Palmitate (UNII: 8CRQ2TH63M)
Stearyl alcohol (UNII: 2KR89I4H1Y)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
Shea butter (UNII: K49155WL9Y)
Cetyl alcohol (UNII: 936JST6JCN)
Dimethicone (UNII: 92RU3N3Y1O)
Distearyldimonium chloride (UNII: OM9573ZX3X)
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61) (UNII: 12GIN16K1G)
Glyceryl monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
COCOA BUTTER (UNII: 512OYT1CRR)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
Phenoxyethanol (UNII: HIE492ZZ3T)
Benzyl alcohol (UNII: LKG8494WBH)
Edetate disodium (UNII: 7FLD91C86K)
Sodium metabisulfite (UNII: 4VON5FNS3C)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43251-3345-1	1 in 1 CARTON	01/10/2013
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 43251-3345-2	3 g in 1 PACKET; Type 0: Not a Combination Product	01/10/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	01/10/2013

Labeler - LaCorium Health USA Inc (111254392)

Establishment
Name	Address	ID/FEI	Business Operations
Scental Pacific Pty Ltd		744482427	MANUFACTURE(43251-3345) , ANALYSIS(43251-3345) , LABEL(43251-3345) , PACK(43251-3345)

Establishment
Name	Address	ID/FEI	Business Operations
Australian Laboratory Services Pty Ltd		758817084	ANALYSIS(43251-3345)