tcx skincare®

tcx skincare®
SPL v6
SPL
SPL Set ID c3be950b-28cf-47c2-9570-ebd46e43b1ba
Route
topical
Published
Effective Date 2025-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
oatmeal (2 g)
Inactive Ingredients
water glycerin carbomer copolymer type a (allyl pentaerythritol crosslinked) cetyl palmitate mineral oil medium-chain triglycerides cetyl alcohol glyceryl 1-stearate dimethicone, unspecified peg-40 monostearate sodium hydroxide phenoxyethanol dmdm hydantoin iodopropynyl butylcarbamate octyldodecanol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2012-05-17

Purpose

Skin protectant

Description

Colloidal Oatmeal 2%


Medication Information

Warnings
  • For external use only
Uses
  • Temporarily protects and helps relieve minor skin irritation and itching due to dry skin and eczema
Purpose

Skin protectant

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

Description

Colloidal Oatmeal 2%

Active Ingredient

Colloidal Oatmeal 2%

When Using This Product:
  • Do not get into eyes
  • Stop use and ask doctor if condition worsens
Keep Out of Reach of Children.

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

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


Structured Label Content

Warnings
  • For external use only
Uses
  • Temporarily protects and helps relieve minor skin irritation and itching due to dry skin and eczema
Purpose

Skin protectant

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

Active Ingredient

Colloidal Oatmeal 2%

When Using This Product: (When using this product:)
  • Do not get into eyes
  • Stop use and ask doctor if condition worsens
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Package/label Principal Display Panel Carton Label (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 (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


Advanced Ingredient Data


Raw Label Data

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