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Antifungal by Blaine Labs Inc.

Dosage form: cream
Ingredients: UNDECYLENIC ACID 4.8mg in 36.97mL
Labeler: Blaine Labs Inc.
NDC Code: 63347-200

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.

Antifungal - 200

DRUG FACTS
Active 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

ANTIFUNGAL 
undecylenic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID4.8 mg  in 36.97 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
UREA 
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) 
EDETATE DISODIUM 
COCO-CAPRYLATE/CAPRATE 
POLYSORBATE 60 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
STEARIC ACID 
PEG-100 STEARATE 
LAVENDER OIL 
TEA TREE OIL 
ALOE VERA LEAF 
CLOTRIMAZOLE 
TROLAMINE 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:63347-200-0136.97 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/01/2016
Labeler - Blaine Labs Inc. (017314571)
Registrant - Blaine Labs Inc. (017314571)
Establishment
NameAddressID/FEIOperations
Blaine Labs Inc.017314571manufacture(63347-200)

 
Blaine Labs Inc.

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Medically reviewed on Apr 4, 2018

Further information

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

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