TCX Skincare

Dosage form: cream
Ingredients: OATMEAL 2mL in 100mL
Labeler: Theraceutix, LLC
NDC Code: 49449-100

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.

tcx skincare® Unique Hydromimetics™

Active ingredient

Colloidal Oatmeal 2%

Purpose

Skin protectant

Uses
  • Temporarily protects and helps relieve minor skin irritation and itching due to dry skin and eczema

Warnings
  • For external use only

Keep out of reach of children.

When using this product:

  • Do not get into eyes
  • Stop use and ask doctor if condition worsens

Directions
  • Apply to affected areas of skin twice daily

Inactive ingredients

Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcohol, Cetyl Palmitate, Dimethicone, DMDM Hydantoin, Glycerin, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Mineral Oil, Octyldodecanol, PEG-40 Stearate, Phenoxy Ethanol, Sodium Hydroxide, Water

Package/Label Principal Display Panel - Carton Label

ECZEMA AND DRY SKIN RELIEF
Skin Protectant

tcx skincare®
Unique Hydromimetics™

2 fl oz/59 mL

tcx skincare® Unique Hydromimetics™ presents

Hydromimetics™, a natural breakthrough clinically-proven to temporarily relieve symptoms associated with eczema and dry skin. A superior, steroid-free, natural formula developed by doctors. Perfect for face, body and those with sensitive skin.

Fragrance and paraben free.Tested by immunologists.Non-comedogenic.

tcxskincare.com

Carton Label

Package/Label Principal Display Panel - Sample Label

tcx skincare®
Unique Hydromimetics™

0.3 oz

Eczema and Dry Skin Relief
Skin Protectant

Directions: Apply to affected areas of skin twice daily

SAMPLE NOT FOR RESALE

tcxskincare.com

Sample Label

TCX SKINCARE 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49449-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (OATMEAL) OATMEAL2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CETYL PALMITATE 
MINERAL OIL 
MEDIUM-CHAIN TRIGLYCERIDES 
CETYL ALCOHOL 
GLYCERYL 1-STEARATE 
DIMETHICONE 
PEG-40 STEARATE 
SODIUM HYDROXIDE 
PHENOXYETHANOL 
DMDM HYDANTOIN 
IODOPROPYNYL BUTYLCARBAMATE 
OCTYLDODECANOL 
Packaging
#Item CodePackage Description
1NDC:49449-100-0159 mL in 1 JAR
2NDC:49449-100-029 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/17/2012
Labeler - Theraceutix, LLC (078353793)
Establishment
NameAddressID/FEIOperations
Fragrance Manufacturing, Inc.793406000MANUFACTURE(49449-100)

Revised: 06/2012
 
Theraceutix, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)