NATRALIA ANTI-ITCH SOOTHING- oatmeal and menthol cream 
LaCorium Health USA Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Natralia™ Anti-Itch Soothing Cream

Drug Facts

Active IngredientsPurpose        
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)

Principal Display Panel - 85 g Tube Carton
NATRALIA ANTI-ITCH SOOTHING 
oatmeal and menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43251-3345
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL20 mg  in 1 g
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43251-3345-11 in 1 CARTON01/10/201306/30/2020
185 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:43251-3345-23 g in 1 PACKET; Type 0: Not a Combination Product01/10/201306/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34701/10/201306/30/2020
Labeler - LaCorium Health USA Inc (111254392)
Establishment
NameAddressID/FEIBusiness Operations
Australian Laboratory Services Pty Ltd 758817084ANALYSIS(43251-3345)

Revised: 6/2020
Document Id: ebeeba92-f0a5-4026-b8fd-07787a821233
Set id: 4dc41404-0f2f-4b88-934d-9964a1d0b511
Version: 4
Effective Time: 20200622
 
LaCorium Health USA Inc