APOCREME- povidone iodine emulsion

Apocreme by

Drug Labeling and Warnings

Apocreme by is a Otc medication manufactured, distributed, or labeled by Microdermis Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

APOCREME 
povidone iodine emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59426-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59426-002-04	1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/21/2015

Labeler - Microdermis Corporation (969967988)