Tcx Skincare Cream
FDA Label NDC 49449-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Theraceutix, Llc for the product Tcx Skincare (NDC 49449-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children., directions, inactive ingredients, package/label principal display panel - carton label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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 (C3be950b 28cf 47c2 9570 Ebd46e43b1ba 01)

Carton Label (C3be950b 28cf 47c2 9570 Ebd46e43b1ba 01)

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

* Please review the disclaimer below.