Label: DGH ADVANCED FORMULA SCAR SKIN PROTECTANT- allantoin gel

  • 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 December 15, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Allantoin 0.5%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve chapped or cracked skin.

  • Warnings

    For external use only.

    When using this product

    ⬥
    Do not get into eyes

    Stop use and consult a doctor if

    ⬥
    condition worsens
    ⬥
    symptoms last more than 7 days or clear up and occur again within a few days

    Do not use on

    ⬥
    Deep or puncture wounds
    ⬥
    animal bites
    ⬥
    serious burns

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    ⬥
    apply as needed
  • Other information

    store at room temperature.

  • Inactive ingredients

    water, PEG-4, glycerin, alcohol denat., propylene glycol, xanthan gum, allium cepa (onion) bulk extract, soy lecithin, panthenol, sodium hyaluronate, carbomer, sodium hydroxide, phenoxyethanol, ethylhexylglycerin, fragrance

  • Questions or comments?

    1-888-309-9030

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY OLD EAST MAIN CO.
    100 MISSION RIDGE
    GOODLETTSVILLE, TN 37072

  • PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

    DG™ | health

    Compare to the
    active ingredient
    of Mederma®
    Advanced Scar Gel*

    Advanced Formula

    Scar Gel

    Skin Protectant

    Allantoin 0.5% / Skin Protectant

    • Helps to reduce the appearance of
      OLD and NEW scars resulting from
      acne, burns, injury, surgery
    • 1x Daily Skin Protectant

    NET WT 1.76 OZ (50 g)

    PRINCIPAL DISPLAY PANEL - 50 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    DGH ADVANCED FORMULA SCAR SKIN PROTECTANT 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-540
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    Glycerin (UNII: PDC6A3C0OX)  
    Alcohol (UNII: 3K9958V90M)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Onion (UNII: 492225Q21H)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Panthenol (UNII: WV9CM0O67Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-540-011 in 1 CARTON12/09/2021
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34712/09/2021
    Labeler - Dolgencorp Inc (068331990)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(55910-540)
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