Label: TERPENICOL- undecylenic acid cream
- NDC Code(s): 63347-601-01
- Packager: Blaine Labs Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 21, 2023
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- DRUG FACTSACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS:
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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.
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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. 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.
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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 - TERPENICOL ANTIFUNGAL CREAM PRODUCT LABEL
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INGREDIENTS AND APPEARANCE
TERPENICOL
undecylenic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63347-601 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 4.55 g in 37.5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) UREA (UNII: 8W8T17847W) HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5) EDETATE DISODIUM (UNII: 7FLD91C86K) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCOL STEARATE (UNII: 0324G66D0E) PEG-100 STEARATE (UNII: YD01N1999R) LAVENDER OIL (UNII: ZBP1YXW0H8) TEA TREE OIL (UNII: VIF565UC2G) ALOE VERA LEAF (UNII: ZY81Z83H0X) CLOTRIMAZOLE (UNII: G07GZ97H65) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63347-601-01 37.5 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 06/19/2017 Labeler - Blaine Labs Inc. (017314571) Registrant - Blaine Labs Inc. (017314571) Establishment Name Address ID/FEI Business Operations Blaine Labs Inc. 017314571 manufacture(63347-601)
