PINCELADAS PARA HONGOS NAVARRO- undecylenic acid liquid

Pinceladas Para Hongos Navarro by

Drug Labeling and Warnings

Pinceladas Para Hongos Navarro by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Undecylenic Acid 20%.................Antifungal

Purpose

Antifungal

Uses

• For the treatment of most athelete's foot, jock itch and ringworm
• For relief if itching, scaling, cracking, burning, redness, soreness, irritations, discomfort, chafing associated with jock itch
• For the relief of itch, scaly skin between toes
• Clears up most athelete's foot infection and with daily use helps keep it from comming back

Warnings

For external use only. Avoid contact with the eyes.

Do not use

• on children under 2 years of age unless directed by a doctor.
• for diaper rash

Stop use and ask doctor if

• For athelete's foot and ringworm, irritation occurs or if there is no improvement within 4 weeks.
• For jock itch, if irritation occurs or if there is no improvement within 2 weeks.

If pregnant or breast-feeding,

ask health professional before use. 

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in use of this product. For athelete'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 athelete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

Other information

• Protect from freezing. If freezing occurs, warm to room temperature 70°-80° F.
• TAMPER EVIDENT DISCLOSURE: Do not use if seal is torn, broken or missing.

Inactive ingredients

• isopropyl alcohol 99%, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PINCELADAS PARA HONGOS NAVARRO 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-119-01	1 in 1 CARTON	02/21/2012
1		30 mL in 1 BOTTLE, WITH APPLICATOR; 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	02/21/2012

Labeler - Menper Distributors, Inc. (101947166)