Label: TRIDERMA STUBBORN DIAPER RASH RELIEF- allantoin, dimethicone cream

  • NDC Code(s): 10738-068-20, 10738-068-25, 10738-068-40, 10738-068-45, view more
    10738-068-50, 10738-068-55
  • Packager: Genuine Virgin Aloe Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 20, 2019

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients

    Allantoin 1.5%
    Dimethicone 2.0%

  • Purpose

    Skin Protectant

  • INDICATIONS & USAGE

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

  • 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 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.

  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    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

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

  • SPL UNCLASSIFIED SECTION

    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

    image description

  • Packaging

    image description

  • Packaging

    image description

  • Packaging

    image description

  • Packaging

    image description

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    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)