TRIDERMA STUBBORN DIAPER RASH RELIEF- allantoin, dimethicone cream 
Genuine Virgin Aloe 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.

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TRIDERMA Stubborn Diaper Rash™ Relief Cream

Drug Facts

Active ingredients

Allantoin 1.5%
Dimethicone 2.0%

Purpose

Skin Protectant

Uses •Helps treat and prevent diaper rash •Helps seal out wetness •Temporarily protects and helps relieve chafed, chapped or cracked skin

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 Change wet/soiled diapers promptly. Cleanse diaper area and allow to dry. Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged.

Other information •Store at room temperature •Keep carton for important information.

Inactive ingredients: water, butyrospermum parkii (shea) butter, glycerin, glyceryl stearate SE, cera alba (beeswax), cetearyl alcohol, carthamus tinctorius (safflower) seed oil, avena sativa (oat) kernel flour, polysorbate 60, polysorbate 80, cetyl esters, zinc PCA, sodium PCA, aloe barbadensis leaf juice*, panthenol (pro-vitamin B5), tocopheryl acetate (vitamin E), glyceryl stearate, sorbic acid, sodium hyaluronate, sodium phytate, sodium hydroxide, cetyl potassium phosphate, xanthan gum, phenoxyethanol, ethylhexylglycerin. *Certified Organic Ingredient - Mayacert Certifier

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

Helps treat & prevent diaper rash

Helps seal out wetness

Dermatologist Tested

This maximum strength cream works quickly to help relieve everyday or hard-to-heal, stubborn diaper rash.

Stubborn diaper rash can be result of changes in diet, medication, or prolonged wetness.

Made with essential botanicals, vitamins, AP4 ® Organic Aloe * Complex and clinically proven skin protectants, this soothing cream helps promote healing after the 1st use.

AP4 ® Organic Aloe* Complex - proprietary soothing botanical blend

Colloidal Oats - helps soothe & relieve irritated skin

Shea Butter - soothes & moisturizes

Beeswax - calming properties

Zinc PCA - additional healing

Also try:

Stubborn Eczema Itch™ Relief Cream

Aloe Healing & Cleansing Gel™

Daily Calming™ Moisturizer

Maximum Strength
Healing Botanicals

Stubborn Diaper Rash™ Relief Cream contains more healing power and is less sticky/gooey than most traditional diaper rash creams.

• Works quickly
• Soothes tender skin
• Helps prevent diaper rash from recurring

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 ©2019 0919

Packaging

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TRIDERMA STUBBORN DIAPER RASH RELIEF 
allantoin, dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10738-068
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1.5 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
WHITE WAX (UNII: 7G1J5DA97F)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
OATMEAL (UNII: 8PI54V663Y)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SORBIC ACID (UNII: X045WJ989B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
POTASSIUM PHOSPHATE, TRIBASIC (UNII: 16D59922JU)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10738-068-501 in 1 CARTON10/31/2019
1NDC:10738-068-5514 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:10738-068-201 in 1 CARTON10/31/2019
2NDC:10738-068-2562 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:10738-068-401 in 1 CARTON10/31/2019
3NDC:10738-068-45113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/31/2019
Labeler - Genuine Virgin Aloe Corporation (961374147)
Establishment
NameAddressID/FEIBusiness Operations
Genuine Virgin Aloe Corporation961374147manufacture(10738-068)

Revised: 2/2023
Document Id: f3bd79ab-be99-e676-e053-2a95a90ad560
Set id: f8f3ae0b-aa55-4c2f-8823-54268524917b
Version: 3
Effective Time: 20230202
 
Genuine Virgin Aloe Corporation