DERMACED MAXIMUM STRENGTH ANTI-FUNGAL- undecylenic acid liquid

Dermaced Maximum Strength Anti-Fungal by

Drug Labeling and Warnings

Dermaced Maximum Strength Anti-Fungal by is a Otc medication manufactured, distributed, or labeled by Dermaced, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

DERMACED MAXIMUM STRENGTH ANTI-FUNGAL 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71515-832
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRONELLA OIL (UNII: QYO8Q067D0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
CLOVE OIL (UNII: 578389D6D0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71515-832-01	1 in 1 BOX	06/29/2017
1		15 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	06/29/2017

Labeler - Dermaced, LLC (080703517)