APOCREME- povidone iodine emulsion 
Microdermis Corporation

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.

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Apocreme

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

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

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)

Revised: 6/2015
Document Id: fe3ee5d2-630d-4532-ad0f-3895e11f5322
Set id: 1a46eac9-2543-4432-994a-cfc02f2177ba
Version: 1
Effective Time: 20150621
 
Microdermis Corporation