Label: DERMAGREEN SKIN CARE- allantoin, lidocaine cream

  • NDC Code(s): 83363-003-00
  • Packager: Healthy Gourmet Plus, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • Drug Facts

  • Active ingredients

    Allantoin 1%

    Lidocaine 1%

    Purpose

    Skin Protectant

    External Analgesic

  • Uses

    • for the temporary relief of pain associated with minor burns or minor skin irritations
    • temporarily protects minor
    • cuts
    • scrapes
    • burns
    • temporarily protects chapped or cracked skin
  • Warnings

    For external use only.

    Do not use

    • on deep or puncture wounds
    • on animal bites
    • on serious burns
    • in large quantities, particularly over raw surfaces or blistered areas

    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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children over 12 years: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period.
    • Children under 12 years: ask a doctor.
  • Inactive ingredients

    African oil palm oil, almond oil, alpha-tocopheryl acetate, beeswax, bitter orange extract, buckthorn oil, C10-18 triglyceride, carrot root extract, evening primrose oil, frankincense extract, geranium extract, hydrogenated coconut oil, lavender extract, lemongrass extract, paraffin wax, patchouli oil, shea butter, stearic acid, sunflower oil, wheat germ oil, white flower oil, ylang-ylang extract.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    DERMAGREEN SKIN CARE 
    allantoin, lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83363-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN10 mg  in 1 mL
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7)  
    C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
    CARROT (UNII: L56Z1JK48B)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    GERANIUM ROBERTIANUM LEAF (UNII: 6H429I0Y3L)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83363-003-0030 mL in 1 JAR; Type 0: Not a Combination Product11/21/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/21/2023
    Labeler - Healthy Gourmet Plus, Inc (083200862)
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