Label: TRIDERMA PROTECT AND HEAL NON- GREASY BARRIER- allantoin, dimethicone cream

  • NDC Code(s): 10738-061-45, 10738-061-50, 10738-061-55
  • Packager: Genuine Virgin Aloe Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 31, 2024

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

  • Drug Facts

  • Active ingredients

    Allantoin 1.5%

    Dimethicone 2%

  • Purpose

    Skin Protectant

  • Uses •helps treat and prevent diaper rash. Protects chafed skin/minor skin irritation due to/associated with diaper rash •helps protect from/seal out wetness •temporarily protect 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 •do not get into eyes 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 •gently clean the irritated area before use. Then apply a generous layer of cream. It can be left on thick or rubbed into skin. Use as many times a day as necessary until healed. For continuous protection and healthy skin, use daily or as needed.

  • STORAGE AND HANDLING

    Other information store at room temperature use on infants, children or adults

  • 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, aloe barbadensis leaf juice*, polysorbate 60, polysorbate 80, cetyl esters, zinc PCA, sodium PCA, panthenol (pro-vitamin B-5), tocopheryl acetate (vitamin E), glyceryl stearate, silica, sodium hyaluronate, sodium phytate, potassium cetyl phosphate, xanthan gum, sodium hydroxide, phenoxyethanol, ethylhexylglycerin.*Certified Organic Ingredient - Mayacert Certifier

  • QUESTIONS

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

  • SPL UNCLASSIFIED SECTION

    Helps treat and prevent diaper rash
    Temporarily protects and helps relieve chafed, chapped, or cracked skin

    AP4 ® BOTANICAL

    ALOE VERA COMPLEX

    Allantoin & Dimenthicone

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

  • Packaging

    one

  • Packaging

    two

  • Packaging

    three

  • INGREDIENTS AND APPEARANCE
    TRIDERMA PROTECT AND HEAL NON- GREASY BARRIER 
    allantoin, dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10738-061
    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)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    OATMEAL (UNII: 8PI54V663Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    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:10738-061-45113 g in 1 TUBE; Type 0: Not a Combination Product08/30/2019
    2NDC:10738-061-501 in 1 CARTON08/30/2019
    2NDC:10738-061-5514 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/30/2019
    Labeler - Genuine Virgin Aloe Corporation (961374147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Genuine Virgin Aloe Corporation961374147manufacture(10738-061)