Label: SCARZEN- dimethicone lotion

  • 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 September 3, 2018

If you are a consumer or patient please visit this version.

  • DRUG FACTS:

  • ACTIVE INGREDIENTS:

    Dimethicone 5.00%

    Skin Protectant

  • USES:

    Temporarily protects and helps relieve chapped or cracked skin

  • WARNINGS:

    • For external use only.
    • Avoid contact with eyes.

    Stop use and ask a doctor 

    • if condition worsens or 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 or serious burns.

    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):

    Cleanse the affected area and allow to dry. Apply as needed.

  • INACTIVE INGREDIENTS:

    Aqua (Deionized Water), Aloe Barbadensis (Aloe Vera Gel) Juice, Glyceryl Stearate, PEG-100 Stearate, Carthamus Tinctorius (Sunflower) Oil, Stearic Acid, Cetyl Alcohol, Butylene Glycol, Glycerin, Sodium Ascorbyl Phosphate (Vitamin C), Tocopheryl Acetate (Vitamin E), Hyaluronic Acid, Zingiber Officinale (Ginger) Extract, Pyridoxine HCL (Vitamin B6), Pantothenic Acid (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Disodium EDTA, Silica, Triethanolamine, Parfum (Fragrance), Phenoxyethanol, Ethylhexylglycerin.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SCARZEN 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71574-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    GINGER (UNII: C5529G5JPQ)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    PANTOTHENIC ACID (UNII: 19F5HK2737)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71574-500-721 in 1 BOX08/01/2018
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2018
    Labeler - Village Pharma LLC (080749749)