Label: ECZEMA ITCH RELIEF WASH AND SHAMPO- colloidal oatmeal shampoo

  • NDC Code(s): 10738-162-23
  • 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 January 31, 2023

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  • Active Ingredient

    Colloidal Oatmeal 1.5%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to: •eczema •rashes •poison ivy •insect bites

  • Warnings

    For external use only

    When using this product • patch test before use • Keep out of eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if • condition worsens • symptoms last for more than 7 days, or clear and occur again in a few days

    Do not use • on deep puncture wounds • on animals • on bites • on serious burns

    Keep out of reach of children. If swallowed get medical help and contact a Poison Control Center right away.

  • Directions

    Dispense a dime to quarter-sized amount into palm, gently massage onto wet skin and hair. Rinse and towel dry. For extra cleansing, allow to sit for 30 seconds and then rinse.

  • Ingredients

    water, salvia officinalis (sage) leaf extract, equisetum arvense (horsetail) extract, calendula officinalis (marigold) flower extract, chamomilla recutita (chamomile) flower extract, panax ginseng root extract, citrus medica limonum (lemon) peel extract, aloe barbadensis leaf extract, sodium methyl 2-sulfolaurate, disodium 2-sulfolaurate, cocamidopropyl betaine, lauramide mea, cetrimonium chloride, peg-150 distearate, sodium c14-16 olefin sulfonate, polyquaternium-7, glycol distearate, laureth-4, goat’s milk, panthenol (pro-vitamin B5), citric acid, phenoxyethanol, caprylyl glycol, ethylhexylglycerin, hexylene glycol.

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Triderma MD Baby

    Eczema Itch Relief Wash & Shampoo

    Helps relieve minor skin irritation & itching due to eczema & rashes

    Dermatologist Tested

    Colloidal Oatmeal

    Skin Protectant

    12 Fl OZ (355 mL)

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    ECZEMA ITCH RELIEF WASH AND SHAMPO 
    colloidal oatmeal shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10738-162
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURIC MONOETHANOLAMIDE (UNII: 098P2IGT76)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV)  
    DISODIUM 2-SULFOLAURATE (UNII: 329M3829G2)  
    GOAT MILK (UNII: XE5K5I4RP7)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CHAMOMILE (UNII: FGL3685T2X)  
    LEMON PEEL (UNII: 72O054U628)  
    LAURETH-4 (UNII: 6HQ855798J)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WATER (UNII: 059QF0KO0R)  
    SAGE (UNII: 065C5D077J)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10738-162-23355 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2020
    Labeler - Genuine Virgin Aloe Corporation (961374147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Genuine Virgin Aloe Corporation961374147manufacture(10738-162)
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