TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF- colloidal oatmeal cream

TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF by

Drug Labeling and Warnings

TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF by is a Otc medication manufactured, distributed, or labeled by Genuine Aloe Virgin Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Colloidal Oatmeal 1.5%

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes

WARNINGS

Warnings For external use only

Do not use on deep puncture wounds on infections on lacerations
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Stop use and ask a doctor if condition worsens or does not improve within 7 days

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions apply twice a day or as needed.

STORAGE AND HANDLING

Other informationstore at room temperature keep carton for important information.

INACTIVE INGREDIENT

Inactive ingredients: water, cetearyl alcohol, urea, isopropyl palmitate, arnica montana flower extract, glycerin, polysorbate 60, cera alba (beeswax), dimethicone, allantoin,zinc PCA, sodium PCA, aloe barbadensis leaf juice*, panthenol (pro-vitamin B5), butyrospermum parkii (shea) butter, tocopheryl acetate (vitamin E), sodium hyaluronate, cetyl alcohol, sodium phytate, sodium hydroxide, phenoxyethanol, ethylhexylglycerin.

*Certified Organic Ingredient - Mayacert Certifier

QUESTIONS

Questions? 1-800-279-7282 M-F 8am-4pm PST

SPL UNCLASSIFIED SECTION

Helps relieve minor skin irritation & itching due to eczema & rashes

Dermatologist Tested

Colloidal Oatmeal

Skin Protectant

This concentrated botanical cream helps relieve extra dry, red or irritated skin due to eczema and rashes.

It provides long-lasting moisture and powerful, yet gentle, itch relief.

Enriched with essential botanicals, AP4® Organic Aloe* Complex and clinically proven Colloidal Oats, it provides
soothing relief for all ages.

AP4® Organic Aloe* Complex - proprietary soothing botanical blend

Colloidal Oats - helps soothe & relieve itching, rashes & eczema

Arnica Montana - known to help soothe irritated skin

Shea Butter - soothes & moisturizes

Vitamins, Beeswax, Allantoin & Zinc PCA

For healthier skin, also try:
Eczema Itch Relief Wash & Shampoo

Healing All Purpose Cream

Daily Calming™ Moisturizer

Maximum Strength
Healing Botanicals

Stubborn Eczema Itch™ Relief Cream provides the special care needed to help protect sensitive skin against dryness, rashes and
eczema related symptoms that can appear anywhere on the body.

• Works quickly
• Soothes, moisturizes & protects
• Powerful itch relief

Clinically Tested, Safe for Sensitive Skin
Non-Greasy No Added Fragrance
Free from Cortisone, Steroids & Parabens

EXPERTS IN SKIN HEALING SINCE 1992

TriDerma MD® provides healing solutions for irritated skin without harmful side effects.

It all began after one woman struggled to find safe and effective healing for her own skin problem.

This journey led to the creation of our proprietary AP4® Organic Aloe* Complex which is key to all our products.

QUALITY YOU CAN FEEL, RESULTS YOU CAN SEE.®

Each product is made using this powerful complex plus nature’s best botanicals and clinically proven ingredients.

We are passionate in our pursuit to create fast healing products that work.

Learn More at www.triderma.com

MADE IN THE USA

Dist. by: Genuine Virgin Aloe Corp., Corona, CA 92879 

Packaging

INGREDIENTS AND APPEARANCE

TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
UREA (UNII: 8W8T17847W)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
YELLOW WAX (UNII: 2ZA36H0S2V)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALLANTOIN (UNII: 344S277G0Z)
ZINC PIDOLATE (UNII: C32PQ86DH4)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
SHEA BUTTER (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHYTATE SODIUM (UNII: 88496G1ERL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10738-069-40	1 in 1 CARTON	08/30/2019
1	NDC: 10738-069-45	113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/30/2019

Labeler - Genuine Aloe Virgin Corporation (961374147)

Establishment
Name	Address	ID/FEI	Business Operations
Genuine Aloe Virgin Corporation		961374147	manufacture(10738-069)