MYCO NAIL A ANTIFUNGAL SOLUTION- undecylenic acid liquid 
Kramer Novis

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.

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Myco Nail A
AntiFungal Solution

Drug Facts

Active ingredient

Undecylenic Acid 25% v/v

Purpose

Antifungal

Uses

For the treatment of athlete's foot (tinea pedis), ringworm (tinea corporis). For effective relief of itching, irritation, and burning feet.

Warnings

For external use only. Flammable: Keep away from fire and flame.

Do not use on children under 2 years of age unless directed by a physician.

When using this product avoid contact with the eyes and mucuos membranes.

Stop use and ask a doctor if irritation occurs or is there is no improvement within 4 weeks.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If you are pregnant or breast-feeding consult a health care professional before using this product.

Directions

Clean the affected area and dry thoroughly. Apply a thin layer of Myco Nail A over the affected area twice daily (morning and night) or as directed by a physician. Supervise children in the use of this product. For athlete's foot: pay special attention to spaces between toes; wear well-fitted, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer, consult a physcian.

Other information

Store between 15 - 30 C (50 – 86F).

Do not accept if safety seal is broken or missing.

Inactive ingredients

Benzyl acetate, benzyl alcohol, cetylpyridinium chloride, chloroxylenol, eucalyptol, glacial acetic acid, Isopropyl alcohol, propionic acid, propylene glycol, sodium propionate and triacetin.

Questions or omments:

Kramer Novis, San Juan PR, 1-787-767-2072

PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton

Myco Nail A®

Antifungal Solution

Topical Formula

1 Fl. Oz. 30 ml.

MANUFACTURED IN USA FOR

KRAMER-NOVIS

San Juan, P.R. 00918

PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton
MYCO NAIL A ANTIFUNGAL SOLUTION 
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-242
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ACETATE (UNII: 0ECG3V79ZJ)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
EUCALYPTOL (UNII: RV6J6604TK)  
ACETIC ACID (UNII: Q40Q9N063P)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPIONIC ACID (UNII: JHU490RVYR)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM PROPIONATE (UNII: DK6Y9P42IN)  
TRIACETIN (UNII: XHX3C3X673)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-242-301 in 1 CARTON01/14/2014
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C01/14/2014
Labeler - Kramer Novis (090158395)
Registrant - Kramer Novis (090158395)

Revised: 10/2022
Document Id: 72c48d04-90db-4af0-bc88-3b28f949a04b
Set id: 550358d7-69e8-4ea3-bcf9-d647c457287d
Version: 4
Effective Time: 20221031
 
Kramer Novis