FDA.reportPublic FDA data

TCX Skincare

Manufacturer
Theraceutix, LLC | Fragrance Manufacturing, Inc.
Effective date
2025-12-24
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:28:29

Label at a glance#

ProductTCX Skincare
Active ingredientOATMEAL
Label structure8 sections

Indications and uses

• Temporarily protects and helps relieve minor skin irritation and itching due to dry skin and eczema

Dosage and administration

• Apply to affected areas of skin twice daily

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 2%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve minor skin irritation and itching due to dry skin and eczema

Warnings

WARNINGS SECTION

  • For external use only

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

When using this product:

OTC - WHEN USING SECTION

  • Do not get into eyes
  • Stop use and ask doctor if condition worsens

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply to affected areas of skin twice daily

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ECZEMA AND DRY SKIN RELIEF
Skin Protectant

tcx skincare®
UNIQUE HYDROMIMETICS™

2 fl oz/59 mL

image-01
image-01

Carton Label

Package/Label Principal Display Panel - Sample Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

image-02
image-02

Sample Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1189915colloidal oatmeal 2 % Topical CreamPSN6
1189915colloidal oatmeal 20 MG/ML Topical CreamSCD6
1189915colloidal oatmeal 2 % Topical CreamSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49449-100-01TCX Skincare59 g in 1 JARCREAM596
49449-100-02TCX Skincare9 g in 1 JARCREAM96

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663Y1
OATMEALACTIVE MOIETY8PI54V663Y1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995L1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08X1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL 1-STEARATEINACTIVE INGREDIENT258491E1RZ1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614Y1
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q71
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49449-10049449-100-01, 49449-100-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
CETYL PALMITATE5ZA2S6B08XIACT
MINERAL OILT5L8T28FGPIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL 1-STEARATE258491E1RZIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
PEG-40 MONOSTEARATEECU18C66Q7IACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DMDM HYDANTOINBYR0546TOWIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
OCTYLDODECANOL461N1O614YIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32023-12-12full-release2026-06-01 00:04:07

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 33 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
3 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERYL 1-STEARATEGLYCERYL 1-STEARATE258491E1RZOINTMENT / TOPICAL3 %w/wExact identifier — unii+route
3 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
3 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERYL 1-STEARATEGLYCERYL 1-STEARATE258491E1RZOINTMENT / TOPICAL3 %w/wExact identifier — unii+route
3 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
3 equally ranked IID candidates
GLYCERYL 1-STEARATEGLYCERYL 1-STEARATE258491E1RZOINTMENT / TOPICAL3 %w/wExact identifier — unii+route
3 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TCX SkincareCOLLOIDAL OATMEALTheraceutix, LLCc3be950b-28cf-47c2-9570-ebd46e43b1ba2025-12-24WarningsExact identifier
ndc (package): 49449-100-01
ndc (package): 49449-100-02
ndc (product): 49449-100
ndc11 (package): 49449010001
ndc11 (package): 49449010002
spl id: 600612eb-7f2c-42b7-8b2a-6eb01342aa66
spl set id: c3be950b-28cf-47c2-9570-ebd46e43b1ba

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.