Label: TRIPENICOL C- undecylenic acid cream
- NDC Code(s): 73352-555-01
- Packager: Trifluent Pharma LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 19, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- USES
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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.
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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.
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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
- PRINCIPAL DISPLAY PANEL - 37.0 mL Bottle Label
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INGREDIENTS AND APPEARANCE
TRIPENICOL C
undecylenic acid creamProduct 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)
