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Dermaced Maximum Strength Anti-Fungal

Medically reviewed on Jun 29, 2017

Dosage form: liquid
Ingredients: UNDECYLENIC ACID 250mg in 1mL
Labeler: Dermaced, LLC
NDC Code: 71515-832

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.

Dermaced Maximum Strength Anti-Fungal

DRUG FACTS:

Active Ingredient:

Undecylenic Acid 25%

Purpose:

Anti-fungal

Uses:

For cure of most: • ringworm (tinea corporis) • athletes foot (tinea pedis). For the relief of: • itching • scaling • creaking • burning • redness • soreness • irritation and discomforts which may accompany these conditions.

Warnings:

For external use only.

Ask a doctor before use 
  • on children under two-years of age.

DO NOT USE

on diaper rash. When using this product avoid contact with eyes.

Stop use and ask a doctor If
  • irritation occurs • there is no improvement within four weeks.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• Clean and dry affected area with soap and water and dry thoroughly. • Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician. • For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks. • For athletes foot and ringworm. If condition persists for longer, consult a physician, • Intended for use by normally healthy adults only. Persons under the age of 18, or those with highly sensitive or allergic skin should use only as directed by physician. • This product is not meant to be applied directly to the scalp or nails.

Other Ingredients:

Cymbopogon Nardus (Citronella) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzygium Aromaticum (Clovebud) Oil, Tocopheryl Acetate (Vitamin E).

Package Labeling:

DERMACED MAXIMUM STRENGTH ANTI-FUNGAL 
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71515-832
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRONELLA OIL 
LAVENDER OIL 
MELALEUCA ALTERNIFOLIA LEAF 
ALMOND OIL 
JOJOBA OIL 
CLOVE OIL 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:71515-832-011 BOTTLE in 1 BOX
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/29/2017
Labeler - Dermaced, LLC (080703517)

 
Dermaced, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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