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TCX Skincare

Theraceutix, LLC

tcx skincare® Unique Hydromimetics™


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Colloidal Oatmeal 2%

Purpose

Skin protectant

TCX Skincare 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

TCX Skincare
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

TCX Skincare
Sample Label

TCX Skincare

Colloidal Oatmeal CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49449-100
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Oatmeal OATMEAL 2 mL

Inactive Ingredients

Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:49449-100-01 59 in 1 JAR
2 NDC:49449-100-02 9 in 1 JAR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2012-05-17


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