Label: PINCELADAS GOYESCAS ORIGINAL FUNGICIDE- undecylenic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 11856-3367-1 - Packager: GOYESCAS OF FLA
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated October 19, 2015
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- Official Label (Printer Friendly)
- Warnings
- Inactive Ingredients
- Uses
- Purpose
- Warnings
- Active Ingredients
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Directions
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.
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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.
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INGREDIENTS AND APPEARANCE
PINCELADAS GOYESCAS ORIGINAL FUNGICIDE
undecylenic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11856-3367 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 SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM PROPIONATE (UNII: DK6Y9P42IN) D&C RED NO. 17 (UNII: ND733RX3JN) PROPIONIC ACID (UNII: JHU490RVYR) WATER (UNII: 059QF0KO0R) BENZOCAINE (UNII: U3RSY48JW5) 2,3-DIHYDROXY BENZOIC ACID (UNII: 70D5FBB392) BORIC ACID (UNII: R57ZHV85D4) D&C GREEN NO. 6 (UNII: 4QP5U84YF7) D&C YELLOW NO. 11 (UNII: 44F3HYL954) ISOPROPYL ALCOHOL (UNII: ND2M416302) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11856-3367-1 1 in 1 BOX 1 33 mL in 1 BOTTLE, SPRAY; 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)