PINCELADAS GOYESCAS ORIGINAL BRUSH ON FUNGICIDE- undecylenic acid liquid

Pinceladas Goyescas Original by

Drug Labeling and Warnings

Pinceladas Goyescas Original by is a Otc medication manufactured, distributed, or labeled by GOYESCAS OF FLA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

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.

INGREDIENTS AND APPEARANCE

PINCELADAS GOYESCAS ORIGINAL  BRUSH ON FUNGICIDE
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11856-3365
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11856-3365-1	1 in 1 BOX
1		33 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/01/1958

Labeler - GOYESCAS OF FLA (032506248)