Label: APOCREME- povidone iodine emulsion

  • 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 June 21, 2015

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  • Drug Facts

  • Active ingredient

    Povidone Iodine 7.5%

    Purpose

    First Aid Antiseptic

  • Uses

    First aid to help reduce bacterial contamination in minor cuts, scrapes, and burns

  • Warnings

    For external use only.

    Do not use

    • In the eyes or apply over large areas of the body. In case of deep or puncture wounds, animals bites, or serious burns, consult a doctor
    • Longer than 1 week unless directed by a doctor

    Stop use and ask a doctor

    If the condition persists or gets worse.

    Keep out of reach of children.

    In case of accidental overdose, contact a medical professional or a Poison Control Center immediately.

  • Directions

    • Clean the affected area.
    • Apply a small amount of this product on the area 1 to 3 times daily.
    • May be coveres with a sterile bandage.
    • If bandaged, let dry first.
  • Other information

    Store in a cool dry place, between 20​o​-25​o​ C (66​o​ -77​o​ F)

    Avoid freezing and excessive heat above 40​o​ C (104​o​ F)

  • Inactive ingredients

    Allantoin, Beeswax, Benzalkonium Chloride, Butylene Glycol, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Disodium EDTA, Distearyl Dimonium Chloride, Emulsifying Wax, NF, Glyceryl Laurate, Glyceryl Stearate, Hydeogenated Jojoba Esters, Laureth-7, Nonoxynol-9, Octoxynol-9, PCA, PEG-100 Stearate, Polyacrylamide, Polyglyceryl-3 Diisostearate, Polyquatemium-7, Purified Water, Sclerotium Gum, Stearic Acid, Triethanolamine

  • Questions

    Call (855) 848-5599 www.apocreme.com

  • Product Label

    BottleCarton

  • INGREDIENTS AND APPEARANCE
    APOCREME 
    povidone iodine emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59426-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-7 (UNII: Z95S6G8201)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    PIDOLIC ACID (UNII: SZB83O1W42)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    WATER (UNII: 059QF0KO0R)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59426-002-041 in 1 CARTON
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/21/2015
    Labeler - Microdermis Corporation (969967988)
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