Label: DERMACINRX ZINC OXIDE SKIN HEALING- zinc oxide paste

  • 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 6, 2019

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  • Active ingredient

    Zinc Oxide 20.0%

    (3.0% as Calamine)

    Purpose

    Skin Protectant

  • Uses

    • for the treatment and/or prevention of diaper rash
    • temporarily protects and helps relieve minor skin irritation and itching due to rashes
  • 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

    Keep out of reach of childern.

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

  • Directions

    • cleanse skin with warm water and soap
    • apply paste to area as needed
    • for G-tubes, cleanse as above, apply thin layer and secure with drain sponge or product as directed
  • Other information

    • protect from freezing
    • avoid excessive heat
  • Inactive ingredients:

    Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil, Fragrance, Maltodextrin, Modified Corn Starch, Niacinamide (Vitamin B3), Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petrolatum, Phenoxyethanol, Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E), Zingiber Officinale (Ginger) Root Extract.

  • DermacinRx Zinc Oxide Skin Healing Paste  (4 g packet)

    image description

  • INGREDIENTS AND APPEARANCE
    DERMACINRX ZINC OXIDE SKIN HEALING 
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-563-014 g in 1 PACKET; Type 0: Not a Combination Product08/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/03/2016
    Labeler - PureTek Corporation (785961046)
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