Label: SCAR GEL ADVANCED FORMULA- allantoin cream

  • 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 May 11, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Allantoin 0.5%

  • Purpose

    Skin Protectant

  • Use

    Temporarily protects minor:

    • cuts
    • scrapes
    • burns

    Temporarily protects and helps relieve chapped or cracked skin

  • Warnings

    For external use only.

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    • apply as needed
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    alcohol denatured, allium cepa (onion) bulb extract, carbomer, fragrance, hydrolized collagen, methylparaben, panthenol, PEG-8, purified water, sodium hyaluronate, sodium hydroxide, sorbic acid

  • Questions or comments?

    1-866-323-0107 or visit www.natureplex .com

  • PRINCIPAL DISPLAY PANEL - 35 g Tube Box

    ADVANCED FORMULA

    Natureplex™

    ScarGel
    With
    Allantoin
    Specially Formulated For Scars

    Helps Soften & Smooth
    The Appearance Of Scars

    NET WT. 1.25 Oz.(35g)

    PRINCIPAL DISPLAY PANEL - 35 g Tube Box
  • INGREDIENTS AND APPEARANCE
    SCAR GEL   ADVANCED FORMULA
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.005 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    COLLAGEN ALPHA-1(III) (HUMAN) (UNII: 5D8UAE62VB)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ONION (UNII: 492225Q21H)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-027-011 in 1 BOX11/01/2013
    135 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34711/01/2013
    Labeler - Natureplex LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-027)
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