Search by Drug Name or NDC

NDC 71387-0820-15 Direct Naturals Fungus Clear 100 mg/mL Details

Direct Naturals Fungus Clear 100 mg/mL

Direct Naturals Fungus Clear is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Active Health Solutions. The primary component is UNDECYLENIC ACID.

Product Information

NDC	71387-0820
Product ID	71387-820_4cfb6824-6320-1f9d-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	Direct Naturals Fungus Clear
Proprietary Name Suffix	n/a
Non-Proprietary Name	UNDECYLENIC ACID
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	mg/mL
Substance Name	UNDECYLENIC ACID
Labeler Name	Active Health Solutions
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 71387-0820-15 (71387082015)

Pricing Information	N/A
NDC Package Code	71387-820-15
Billing NDC	71387082015
Package	15 mL in 1 BOTTLE, DROPPER (71387-820-15)
Marketing Start Date	2017-04-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4cfb6c5b-5727-1916-e054-00144ff88e88 Details

DRUG FACTS:

Active Ingredient:

Undecylenic Acid 10.00%

Antifungal

Uses:

For cure of most: • ringworm (tinea corporis) • athlete's foot (tinea pedis). For the relief of: itching • scalling • cracking • 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 UES

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 athlete's foot and ringworm. if condition persists for longer, consult a physician. • internded for us 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

DIRECT NATURALS FUNGUS CLEAR

undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71387-820
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	100 mg in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71387-820-15	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/12/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	04/12/2017

Labeler - Active Health Solutions (816806310)

Revised: 4/2017

Document Id: 4cfb6824-6320-1f9d-e054-00144ff8d46c

Set id: 4cfb6c5b-5727-1916-e054-00144ff88e88

Version: 1

Effective Time: 20170412