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NDC 71515-0832-01 Dermaced Maximum Strength Anti-Fungal 250 mg/mL Details

Dermaced Maximum Strength Anti-Fungal 250 mg/mL

Dermaced Maximum Strength Anti-Fungal is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Dermaced, LLC. The primary component is UNDECYLENIC ACID.

Product Information

NDC	71515-0832
Product ID	71515-832_531ff07b-f26a-293d-e054-00144ff8d46c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Dermaced Maximum Strength Anti-Fungal
Proprietary Name Suffix	n/a
Non-Proprietary Name	UNDECYLENIC ACID
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	250
Active Ingredient Units	mg/mL
Substance Name	UNDECYLENIC ACID
Labeler Name	Dermaced, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2022-12-31

Package

Package Images

NDC 71515-0832-01 (71515083201)

Pricing Information	N/A
NDC Package Code	71515-832-01
Billing NDC	71515083201
Package	1 BOTTLE in 1 BOX (71515-832-01) / 15 mL in 1 BOTTLE
Marketing Start Date	2017-06-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 531ff07b-f26b-293d-e054-00144ff8d46c Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	06/29/2017

Labeler - Dermaced, LLC (080703517)

Revised: 6/2017

Document Id: 531ff07b-f26a-293d-e054-00144ff8d46c

Set id: 531ff07b-f26b-293d-e054-00144ff8d46c

Version: 1

Effective Time: 20170629