TCX SKINCARE- colloidal oatmeal cream

TCX Skincare by

Drug Labeling and Warnings

TCX Skincare by is a Otc medication manufactured, distributed, or labeled by Theraceutix, LLC, Fragrance Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

If swallowed, get medical help or contact a Poison Control Center right away.

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

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

INGREDIENTS AND APPEARANCE

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 g  in 100 g

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 g in 1 JAR; Type 0: Not a Combination Product	05/17/2012
2	NDC: 49449-100-02	9 g in 1 JAR; Type 0: Not a Combination Product	05/17/2012

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)