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
  • 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 February 2, 2023

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  • 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 finalpart34708/30/2019
    Labeler - Genuine Virgin Aloe Corporation (961374147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Genuine Virgin Aloe Corporation961374147manufacture(10738-061)
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