Apocreme
FDA Label NDC 59426-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Microdermis Corporation for the product Apocreme (NDC 59426-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, do not use, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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