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| Product NDC Code | 63347-601 | ||||
|---|---|---|---|---|---|
| Drug Name | Terpenicol |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M005 | ||||
| Labeler Name | Blaine Labs Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.DRUG FACTS ACTIVE INGREDIENT UNDECYLENIC ACID 13%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of 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.
Purpose
Information about the drug product’s indications for use.PURPOSE ANTIFUNGAL
Spl product data elements
Usually a list of ingredients in a drug product.TERPENICOL UNDECYLENIC ACID UNDECYLENIC ACID UNDECYLENIC ACID 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
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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 BLAINE TERPENICOL 601
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API