ANTIFUNGAL- undecylenic acid cream

Antifungal by

Drug Labeling and Warnings

Antifungal by is a Otc medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTSActive Ingredient

Undecylenic Acid 13%

Purpose

Antifungal

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Indications:

Cures Althete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris) and Ringworm (Tinea Corporis). Relieves itching, burning, cracking, scaling itchy, saly sin between the toes and itching burning feet.

Warnings:

Do not use on children under two years of age unless directed by a physician. For external use only. Avoid contact with eyes. If irritation occurs or if there is no improvement within four (4) weeks (for Athlete's Foot or Ringworm) or within two (2) weeks (for Jock Itch), discontinue use and consult a physician.

Directions:

Wash the affected area with soap and water and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a physician. For Athlete's Foot, pay special attention to spaces between the toes; Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For Athlete's Foot and Ringworm, use daily for four (4) weeks. For Jock Itch, use daily for two (2) weeks. If condition persists longer, consult a physician. Wash hands after each use.

Inactive Ingredients

Water, Urea, Hydroxyethylcellulose, Disodium EDTA, COCO Caprylate Caprate, Polysorbate 60, Cetyl Alcohol, Glyceryl Stearate, Stearic Acid, PEG-100 Stearate, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Bardadensis Leaf Juice, Clotrimazole, Triethanolamine, Methylparaben, Propylparaben

Antifungal Cream product label

NDC: 63347-200-01

Antifungal Cream

PRACTICE EXCLUSIVE

Undecylenic Acid 13%

Clotrimazole

1.25 FL OZ

Manufactured by: Blaine Labs, Inc., 11037

Lockport Place, Santa Fe Springs, CA 90670

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INGREDIENTS AND APPEARANCE

ANTIFUNGAL 
undecylenic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	4.8 mg  in 36.97 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
UREA (UNII: 8W8T17847W)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)
EDETATE DISODIUM (UNII: 7FLD91C86K)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG-100 STEARATE (UNII: YD01N1999R)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CLOTRIMAZOLE (UNII: G07GZ97H65)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-200-01	36.97 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/01/2016

Labeler - Blaine Labs Inc. (017314571)

Registrant - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-200)