tcx skincare® Unique Hydromimetics™

tcx skincare® Unique Hydromimetics™

Drug Labeling and Warnings

Drug Details

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TCX SKINCARE- colloidal oatmeal cream 
Theraceutix, LLC

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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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49449-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
MINERAL OIL (UNII: T5L8T28FGP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-40 STEARATE (UNII: ECU18C66Q7)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
OCTYLDODECANOL (UNII: 461N1O614Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49449-100-01	59 mL in 1 JAR
2	NDC: 49449-100-02	9 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/17/2012

Labeler - Theraceutix, LLC (078353793)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing, Inc.		793406000	MANUFACTURE(49449-100)

Revised: 6/2012

Document Id: c3be950b-28cf-47c2-9570-ebd46e43b1ba

Set id: c3be950b-28cf-47c2-9570-ebd46e43b1ba

Version: 1

Effective Time: 20120622

 

Theraceutix, LLC