Tripenicol™ C

Tripenicol™ C
SPL v4
SPL
SPL Set ID 0a7477da-370f-451f-8993-8c675c168696
Route
TOPICAL
Published
Effective Date 2023-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (0.13 g)
Inactive Ingredients
Water Hydroxyethyl Cellulose, Unspecified Aloe Vera Leaf Edetate Disodium Urea Medium-chain Triglycerides Polysorbate 60 Peg-100 Monostearate Cetyl Alcohol Glyceryl Monostearate Stearic Acid Methylparaben Propylparaben Trolamine Clotrimazole Lavender Oil Tea Tree Oil Sodium Polyacrylate (8000 Mw) Hydrogenated Polydecene (1500 Cst) Trideceth-6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-11

Description

DRUG FACTS

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

DRUG FACTS

Uses
  • Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis).
  • Relives discomfort, itching, cracking, burning and scaling, which accompany these conditions.
Section 42229-5

DRUG FACTS

Section 50565-1

Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact poison control center immediately (800)-222-1222.

Warning

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 no 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.

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. Supervise children in the use of this product. 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 Athlete'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. This product is not effective on the scalp or nails. Wash hands after each use.

Active Ingredient

Undecylenic Acid 13%

Other Information

Store in dry area at 20-25°C (68-77°F)

Inactive Ingredients

Aloe barbadensis (Aloe Vera) Leaf Juice, Caprylic/Capric Triglyceride, Cetyl Alcohol, Clotrimazole, Disodium EDTA Dihydrate, Glyceryl Stearate, Hydrogenated Polydecene, Hydroxyethylcellulose, Lavandula angustifolia (Lavender) Oil, Melaleuca alternifolia (Tea Tree) Oil, Methylparaben, PEG-100 Stearate, Polysorbate 60, Propylparaben, Purified Water, Sodium Polyacrylate, Stearic Acid, Trideceth-6, Triethanolamine, Urea

Principal Display Panel 37.0 Ml Bottle Label

TRIFLUENT

PHARMA®

TRIPENICOL™ C

ANTIFUNGAL CREAM

UNDECYLENIC ACID

NDC 73352-555-01

1.25 FL OZ (37.0 mL)

PRODUCT SHOULD BE ADMINISTERED

UNDER THE SUPERVISION OF A

LICENSED MEDICAL PRACTITIONER


Structured Label Content

Uses (USES)
  • Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis).
  • Relives discomfort, itching, cracking, burning and scaling, which accompany these conditions.
Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact poison control center immediately (800)-222-1222.

Purpose (PURPOSE)

Antifungal

Warning (WARNING)

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 no 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.

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. Supervise children in the use of this product. 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 Athlete'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. This product is not effective on the scalp or nails. Wash hands after each use.

Active Ingredient (ACTIVE INGREDIENT)

Undecylenic Acid 13%

Other Information (OTHER INFORMATION)

Store in dry area at 20-25°C (68-77°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

Aloe barbadensis (Aloe Vera) Leaf Juice, Caprylic/Capric Triglyceride, Cetyl Alcohol, Clotrimazole, Disodium EDTA Dihydrate, Glyceryl Stearate, Hydrogenated Polydecene, Hydroxyethylcellulose, Lavandula angustifolia (Lavender) Oil, Melaleuca alternifolia (Tea Tree) Oil, Methylparaben, PEG-100 Stearate, Polysorbate 60, Propylparaben, Purified Water, Sodium Polyacrylate, Stearic Acid, Trideceth-6, Triethanolamine, Urea

Principal Display Panel 37.0 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 37.0 mL Bottle Label)

TRIFLUENT

PHARMA®

TRIPENICOL™ C

ANTIFUNGAL CREAM

UNDECYLENIC ACID

NDC 73352-555-01

1.25 FL OZ (37.0 mL)

PRODUCT SHOULD BE ADMINISTERED

UNDER THE SUPERVISION OF A

LICENSED MEDICAL PRACTITIONER


Advanced Ingredient Data


Raw Label Data

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