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| Product NDC Code | 55505-219 | ||||
|---|---|---|---|---|---|
| Drug Name | Opti-nail 2-in-1 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 313423, 2627287 |
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| Application Number | M005 | ||||
| Labeler Name | Kramer Laboratories | ||||
| 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.Active ingredient Purpose Tolnaftate 1% Anti-fungal
| Tolnaftate 1% | Anti-fungal |
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: Clean affected area with soap and warm water and dry thoroughly. Apply a thin layer of Maximum Strength Antifungal over affected area twice daily (morning and night) or as directed by a doctor. The brush applicator allows for easy application to skin around the nail. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete’s foot pay special attention to spaces between the toes. For athlete’s foot and ringworm, use daily for 4 weeks. For toe fungus, apply to skin around nails. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails. Supervise children in the use of this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera (aloe barbadensis) gel, ascorbic acid (vitamin C), dimethicone, DMDM hydantoin, edetate disodium dihydrate, eucalyptol, glycerin, glyceryl stearate SE, lavender oil, mineral oil, olive oil, PEG-100 stearate, phenoxetol, propylene glycol, tea tree oil, titanium dioxide, alpha tocopheryl acetate (vitamin E), xanthan gum, water
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.Uses proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) helps prevent most athlete’s foot with daily use for effective relief of itching, burning and cracking.
Spl product data elements
Usually a list of ingredients in a drug product.Opti-Nail 2-in-1 Tolnaftate Tolnaftate Tolnaftate Aloe Vera Leaf Ascorbic Acid Dimethicone Dmdm Hydantoin Edetate Disodium Eucalyptol Glycerin Glyceryl Stearate Se Lavender Oil Mineral Oil Olive Oil Peg-100 Stearate Phenoxyethanol Propylene Glycol Tea Tree Oil Titanium Dioxide .Alpha.-Tocopherol Acetate Xanthan Gum Water Label Directions
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.PACKAGE LABEL THE ONLY PRODUCT THAT 1. Improves Nail Appearance AND 2. Kills Fungus Around the Nail NEW Opti-Nail™ 2-in-1 FUNGAL NAIL REPAIR + ANTI-FUNGAL 1 Improves Nail Appearance Fungal Nail Repair Formula Apply directly on nail Visible Results Starting in Just 2 DAYS Net Wt 5mL (.169 fl oz) 2 Kills Fungus Around Nail Maximum Strength Antifungal (1% Tolnaftate) Apply to skin around nail Clinically Proven to Cure & Prevent Fungal Infections* Net Wt 5mL (.169 fl oz) INCLUDES: 1% Tolnaftate Antifungal Solution AND Fungal Nail Repair Formula *restores skin health + cures most athlete's foot Step 1 Apply Fungal Nail Repair Formula Directly On Nail Clinically Proven Formula that results In Healthier Looking Nails ✓ Visible Results Starting in Just 2 Days ✓ Triple Action Formula Lightens, Smooths, and Moisturizes ✓ Easy to Apply & Dries Quickly Apply twice a day for 4 weeks, then use once daily as needed. Fungal Nail Repair Formula Ingredients: Ethyl lactate, glycerin, water, lactic acid, resacetophenone, citric acid (if needed for pH balance). For External Use only. Apply only to nail surface. Avoid contact with eyes and mucus membranes. Do not use if you are allergic to any of the ingredients in this product. Keep out of reach of children. Diabetics should ask a doctor before use. Sunburn Alert: may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. See package insert for full Opti-Nail 2-1 product instructions Do not use if neck band is missing or broken K0322 Fungal Nail Repair Formula does not treat, cure, or prevent fungal infections. © 2022 Kramer Laboratories, Inc. Bridgewater, NJ 08807 Questions or Comments? Call 1-800-824-4894 Patent pending Step 2 Apply Maximum Strength Antifungal On Skin Around Nail Clinically Proven to Cure & Prevent Fungal Infections ✓ Kills Fungus ✓ Stops Itching and Burning ✓ Restores Skin Health + Cures Most Athletes Foot Maximum Strength Anti-Fungal not for nail or scalp fungus. Cures most athlete's foot. Opti-Nail™ 2-in-1 Fungal Nail Repair + Antifungal Directions For Use Always apply step 1 BEFORE Step 2 First clean affected areas with soap and water and dry thoroughly Step 1 Apply Fungal Nail Repair Formula (Green side) to Nail Surface Unscrew the green cap. Using the applicator, apply a thin layer of solution directly on entire affected nail surface twice daily (morning and evening). (Solution looks clear.) Nail surface will appear wet after application. Avoid applying to skin around the nail. After applying, recap tightly and allow treated nails(s) to dry for a few minutes before beginning Step 2. Apply twice a day for 4 weeks, then use once daily as needed to maintain look. For external use only. Avoid contact with skin. Apply only to nail surface. Avoid contact with eyes and mucous membranes. In case of contact with eyes, rinse cautiously with water for several minutes. May cause irritation if applied to skin. Discontinue use in the event of an allergic reaction or irritation. Do not use if you are allergic to any of the ingredients in the product. Keep out of reach of children. Avoid inhalation. Diabetics should ask doctor before use. Sunburn Alert: This product contains alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use sunscreen, wear protective clothing, and limit sun exposure while using this product for a week afterwards. Product is flammable, do not use near an open flame. Fungal Nail Repair Formula Ingredients: Ethyl lactate, glycerin, water, lactic acid, resacetophenone, citric acid (if needed for pH balance). Fungal Nail Repair Formula does not treat, cure, or prevent fungal infections Step 2 Apply Maximum Strength Antifungal (Blue side) to Skin Around Nail Unscrew the blue cap. Using the applicator, apply a thin layer of medicine to skin around nails twice daily (morning and evening). (Medicine looks white to off-white.) After applying, recap tightly and allow treated area to dry for a few minutes before putting on socks and shoes. Apply twice a day for 4 weeks. For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs of it there is no improvement within 4 weeks. Keep out of reach of children. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice. Maximum Strength Antifungal: Active ingredient: Tolnaftate 1% Inactive ingredients: aloe vera (aloe barbadensis) gel, ascorbic acid (vitamin C), dimethicone, DMDM hydantoin, edetate disodium dihydrate, eucalyptol, glycerin, glyceryl stearate SE, lavender oil, mineral oil, olive oil, PEG-100 stearate, phenoxetol, propylene glycol, tea tree oil, titanium dioxide, tocopheryl acetate (vitamin E), xanthan gum, water Maximum Strength Antifungal is not effective for nail or scalp fungus. Cures most athlete's foot. ©2022 Kramer Laboratories, Inc. Bridgewater, NJ 08807 Questions or Comments? Call 1-800-824-4894 Patent pending Store at room temperature 15°−30°C (59°−86°F) K0322
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on children under 2 years of age unless directed by a doctor.
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 THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at room temperature 15º−30ºC (59º−86ºF).
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes.
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 For external use only.
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