Terpenicol - 601

Terpenicol - 601
SPL v3
SPL
SPL Set ID efd99ed1-07d3-4862-ae47-883f7d1c91c6
Route
TOPICAL
Published
Effective Date 2022-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (4.55 g)
Inactive Ingredients
Water Urea Hydroxyethyl Cellulose (140 Cps At 5%) Edetate Disodium Alkyl (c12-15) Benzoate Polysorbate 80 Sorbitan Monolaurate Cetyl Alcohol Glycol Stearate Peg-100 Stearate Lavender Oil Tea Tree Oil Aloe Vera Leaf Clotrimazole Trolamine Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-06-19

Description

UNDECYLENIC ACID 13%

Purpose

ANTIFUNGAL


Medication Information

Purpose

ANTIFUNGAL

Description

UNDECYLENIC ACID 13%

Warnings:

DO NOT USE ON CHILDREN UNDER TWO YEARS OF AGE UNLESS DIRECTED BY A PHYSICIAN. FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. IF IRRITATION OCCURS OR IF THERE IS NOT IMPROVEMENT WITHIN FOUR (4) WEEKS (FOR ATHLETE'S FOOT OR RINGWORM) OR WITHIN TWO (2) WEEKS (FOR JOCK ITCH), DISCONTINUE USE AND CONSULT A PHYSICIAN.

Drug Facts

UNDECYLENIC ACID 13%

Directions:

WASH THE AFFECTED AREA WITH SOAP AND WATER AND DRY THOROUGHLY. APPLY A THIN LAYER OF THE PRODUCT OVER AFFECTED AREA TWICE DAILY (MORNING AND NIGHT), OR AS DIRECTED BY A PHYSICIAN. FOR ATHLETE'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 ALHTLETE'S FOOT AND RINGWORM, USE DAILY FOR FOUR (4) WEEKS. FOR JOCK ITCH, USE DAILY FOR TWO (2) WEEKS. IF CONDITION PERSISTS LONGER, CONSULT A PHYSICIAN. WASH HANDS AFTER EACH USE.

Indications:

CURES ATHLETE'S FOOT (TINEA PEDIS), JOCK ITCH (TINA CRURIS) AND RINGWORM (TINA CORPORIS). RELIEVES ITCHING, BURNING, CRACKING, SCALING, ITCHY, SCALY BETWEEN TOES AND ITCHING, BURNING FEET.

Inactive Ingredients:

WATER, UREA, HYDROXYETHYLCELLULOSE, DISODIUM EDTA, C12-15 ALKYL BENZOATE, POLYSORBATE 80, SORBITAN LAURATE, CETYL ALCOHOL,

GLYCOL STEARATE, PEG-100 STEARATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, ALOE BARDADENSIS LEAF JUICE, CLOTRIMAZOLE, TRIETHANOLAMINE, METHYLPARABEN, PROPYLPARABEN

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Terpenicol Antifungal Cream Product Label

DISPENSED EXCLUSIVELY BY PHYSICIANS

NDC-601-01

BLAINE LABS®

TERPENICOL®

ANTIFUNGAL CREAM

UNDECYLENIC ACID

37.5 mL (1.25 FL OZ)

BLAINE LABS, INC., 11037 LOCKPORT PLACE,

SANTA FE SPRINGS, CA 90670

(800) 307-8818

31100-P-LBL01 REV20170517

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Structured Label Content

Purpose (PURPOSE)

ANTIFUNGAL

Warnings: (WARNINGS:)

DO NOT USE ON CHILDREN UNDER TWO YEARS OF AGE UNLESS DIRECTED BY A PHYSICIAN. FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. IF IRRITATION OCCURS OR IF THERE IS NOT IMPROVEMENT WITHIN FOUR (4) WEEKS (FOR ATHLETE'S FOOT OR RINGWORM) OR WITHIN TWO (2) WEEKS (FOR JOCK ITCH), DISCONTINUE USE AND CONSULT A PHYSICIAN.

Drug Facts (DRUG FACTS)

UNDECYLENIC ACID 13%

Directions: (DIRECTIONS:)

WASH THE AFFECTED AREA WITH SOAP AND WATER AND DRY THOROUGHLY. APPLY A THIN LAYER OF THE PRODUCT OVER AFFECTED AREA TWICE DAILY (MORNING AND NIGHT), OR AS DIRECTED BY A PHYSICIAN. FOR ATHLETE'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 ALHTLETE'S FOOT AND RINGWORM, USE DAILY FOR FOUR (4) WEEKS. FOR JOCK ITCH, USE DAILY FOR TWO (2) WEEKS. IF CONDITION PERSISTS LONGER, CONSULT A PHYSICIAN. WASH HANDS AFTER EACH USE.

Indications: (INDICATIONS:)

CURES ATHLETE'S FOOT (TINEA PEDIS), JOCK ITCH (TINA CRURIS) AND RINGWORM (TINA CORPORIS). RELIEVES ITCHING, BURNING, CRACKING, SCALING, ITCHY, SCALY BETWEEN TOES AND ITCHING, BURNING FEET.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER, UREA, HYDROXYETHYLCELLULOSE, DISODIUM EDTA, C12-15 ALKYL BENZOATE, POLYSORBATE 80, SORBITAN LAURATE, CETYL ALCOHOL,

GLYCOL STEARATE, PEG-100 STEARATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, ALOE BARDADENSIS LEAF JUICE, CLOTRIMAZOLE, TRIETHANOLAMINE, METHYLPARABEN, PROPYLPARABEN

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Terpenicol Antifungal Cream Product Label (TERPENICOL ANTIFUNGAL CREAM PRODUCT LABEL)

DISPENSED EXCLUSIVELY BY PHYSICIANS

NDC-601-01

BLAINE LABS®

TERPENICOL®

ANTIFUNGAL CREAM

UNDECYLENIC ACID

37.5 mL (1.25 FL OZ)

BLAINE LABS, INC., 11037 LOCKPORT PLACE,

SANTA FE SPRINGS, CA 90670

(800) 307-8818

31100-P-LBL01 REV20170517

res


Advanced Ingredient Data


Raw Label Data

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