PINCELADAS GOYESCAS ORIGINAL BRUSH ON FUNGICIDE- undecylenic acid liquid 
GOYESCAS OF FLA

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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Dose

DIRECTIONS:

Clean the affected area and dry thoroughly. Apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor. For athlete’s foot pay special attention to spaces between the toes; change shoes and socks at least at least once daily. For athletes and ring worm use daily for 4 weeks or as directed by a doctor. For jock itch use daily for 2 weeks. If condition persists longer consult a doctor.

Warnings

WARNINGS:

For external use ONLY. If irritation occurs consult your physician. Do not use on children under 2 years. Avoid contact with your eyes and mucous membrane. Keep out of reach of children. If swallowed contact Poison Control Center. Flammable: Keep away from fire and flame.

Inactive Igredients

Inactive Ingredients:

Benzocaine, Benzoic Acid, Boric Acid, D&C green #6, D&C yellow #11, D&C red #17, Isopropyl Alcohol, Propionic Acid, Purified Water, Salicylic Acid, Sodium Propionate and Strong Ammonium.

Use

USES:

For the treatment of athletes foot, jock itch and other fungal infections. For relief of itching burning irritation and discomfort which may accompany these conditions.

Purpose

DRUG FACTS: PURPOSE

Undecylenic Acid 10% Antifungal

Warnings

WARNINGS:

For external use ONLY. If irritation occurs consult your physician. Do not use on children under 2 years. Avoid contact with your eyes and mucous membrane. Keep out of reach of children. If swallowed contact Poison Control Center. Flammable: Keep away from fire and flame.

Active Ingredient

DRUG FACTS:

ACTIVE INGREDIENTS: PURPOSE

Undecylenic Acid 10% Antifungal

CartonCarton

DRUG FACTS:

ACTIVE INGREDIENTS: PURPOSE

Undecylenic Acid 10% Antifungal

USES:

For the treatment of athletes foot, jock itch and other fungal infections. For relief of itching burning irritation and discomfort which may accompany these conditions.

WARNINGS:

For external use ONLY. If irritation occurs consult your physician. Do not use on children under 2 years. Avoid contact with your eyes and mucous membrane. Keep out of reach of children. If swallowed contact Poison Control Center. Flammable: Keep away from fire and flame.

DIRECTIONS:

Clean the affected area and dry thoroughly. Apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor. For athlete’s foot pay special attention to spaces between the toes; change shoes and socks at least at least once daily. For athletes and ring worm use daily for 4 weeks or as directed by a doctor. For jock itch use daily for 2 weeks. If condition persists longer consult a doctor.

Inactive Ingredients:

Benzocaine, Benzoic Acid, Boric Acid, D&C green #6, D&C yellow #11, D&C red #17, Isopropyl Alcohol, Propionic Acid, Purified Water, Salicylic Acid, Sodium Propionate and Strong Ammonium.

Label

PINCELADAS GOYESCAS ORIGINAL  BRUSH ON FUNGICIDE
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11856-3365
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZOCAINE (UNII: U3RSY48JW5)  
BORIC ACID (UNII: R57ZHV85D4)  
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
D&C RED NO. 17 (UNII: ND733RX3JN)  
WATER (UNII: 059QF0KO0R)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM PROPIONATE (UNII: DK6Y9P42IN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11856-3365-11 in 1 BOX
133 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/01/1958
Labeler - GOYESCAS OF FLA (032506248)

Revised: 10/2015
Document Id: 227d9ccb-8783-0f69-e054-00144ff88e88
Set id: 227d9ccb-8782-0f69-e054-00144ff88e88
Version: 1
Effective Time: 20151019
 
GOYESCAS OF FLA