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

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

Sample Label

TCX SKINCARE 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49449-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Fragrance Manufacturing, Inc.793406000MANUFACTURE(49449-100)

Revised: 6/2012
 
Theraceutix, LLC


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