TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF- colloidal oatmeal cream 
Genuine Aloe Virgin Corporation

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.

----------

TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF CREAM

Drug Facts

Active ingredient

Colloidal Oatmeal 1.5%

Purpose

Skin Protectant

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

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.

Directions apply twice a day or as needed.

Other informationstore at room temperature keep carton for important information.

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

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.

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

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

Label

TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10738-069
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10738-069-401 in 1 CARTON08/30/2019
1NDC:10738-069-45113 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:10738-069-201 in 1 CARTON08/30/2019
2NDC:10738-069-2562 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:10738-069-501 in 1 CARTON08/30/2019
3NDC:10738-069-5514 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/30/2019
Labeler - Genuine Aloe Virgin Corporation (961374147)
Establishment
NameAddressID/FEIBusiness Operations
Genuine Aloe Virgin Corporation961374147manufacture(10738-069)

Revised: 1/2023
Document Id: f395ca14-610c-8d42-e053-2995a90a0736
Set id: f5a83e98-da32-49ae-b81d-4279af4b154c
Version: 3
Effective Time: 20230131
 
Genuine Aloe Virgin Corporation