TRIPENICOL C- undecylenic acid cream

Tripenicol C by

Drug Labeling and Warnings

Tripenicol C by is a Otc medication manufactured, distributed, or labeled by Trifluent Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Undecylenic Acid 13%

PURPOSE

Antifungal

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.

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.

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.

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.

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

OTHER INFORMATION

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

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

INGREDIENTS AND APPEARANCE

TRIPENICOL C 
undecylenic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73352-555
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	0.13 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
UREA (UNII: 8W8T17847W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)
CLOTRIMAZOLE (UNII: G07GZ97H65)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)
TRIDECETH-6 (UNII: 3T5PCR2H0C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73352-555-01	37 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	12/11/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M005	12/11/2023

Labeler - Trifluent Pharma LLC (117167281)