FDA Label for Tagrid Antifungal Treament Clotrimazole 1%
View Indications, Usage & Precautions
- DESCRIPTION
- OTC - ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - WHEN USING
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- OTC - QUESTIONS
- INACTIVE INGREDIENT
- OTC - PURPOSE
- OTC - PREGNANCY OR BREAST FEEDING
- INSTRUCTIONS FOR USE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Tagrid Antifungal Treament Clotrimazole 1% Product Label
The following document was submitted to the FDA by the labeler of this product Tagrid Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Tagrid Antifungal Kit (Soap + Cream)
This package contains:
- One bar of antifungal soap with Tolnaftate and herbal ingredients.
- One tube of antifungal cream with Clotrimazole 1% for enhanced relief.
See product labeling below for full directions and warnings. Main instructions on this box are based on soap usage. See cream label for specific use cases.
Questions? Contact [email protected] or visit www.tagridllc.com
Otc - Active Ingredient
Tolnaftate
Clotrimazole 1%
Indications & Usage
- For effective treatment of jock itch, ringworm, athlete's foot, and folliculitis tinea.
- For effective relief of itching, burning, and cracking skin.
- Treats fungal infections of the skin, such as folliculitis, athlete's foot, jock itch, ringworm, and seborrheic dermatitis.
- Effective for relieving symptoms of itching, scaling, redness, and discomfort caused by fungal infections.
- Helps reduce and control fungal skin infections, including:
- tinea corporis (body fungus)
- tinea cruris (groin fungus)
- tinea pedis (foot fungus)
- tinea versicolor
- Can be used on areas prone to fungal growth, such as the scalp, face, chest, back, arms, and legs.
Warnings
For external use only
For external use only.
Otc - Do Not Use
Do not use on children under 2 years of age exceptunder the advice and supervision of a doctor.
on broken, inflamed, or severely irritated skin.
lf you are allergic to Clotrimazole or any other ingredients in this product.
Otc - When Using
When using this product avoid contact with the eyes.
Avoid contact with the eyes. If the product gets into the eyes, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation occurs or if there is no improvement within 2weeks for jock itch.
Stop use and ask a doctor if: a rash appears. the condition does not improve within 2-4 weeks of regular use.
Otc - 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.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
DIRECTIONS
- Wash the affected area well and let the product sit for 1-2 minutes before rinsing.
- Ensure thorough drying of the affected area.
- Supervise children when using this product.
- For patients seeking immediate relief or experiencing severe symptoms, we recommend applying the ointment.
- Please note the potential burning and stinging sensation after application, primarily due to menthol and other natural ingredients.
- Endure any discomfort for 5-10 minutes before experiencing immediate relief.
- Use 1-2 times daily for 4 weeks. If the condition persists longer, consult a doctor.
Adults and children 12 years and over:
- Clean and dry the affected area before application.
- Apply a small amount to the affected area once or twice daily, or as directed by a doctor.
- Use continuously for up to 4 weeks, or as directed by a healthcare provider.
Children under 12 years:
- Ask a doctor before use.
Directions
Other Safety Information
- The cream provided is intended for severe cases.
- Users may experience a burning or stinging sensation upon application.
- This discomfort should be tolerated for 5–10 minutes before subsiding and can be relieved immediately.
store at 20°C to 25°C (68°F-77°F).
see the top panel for lot number and expiration date.
Otc - Questions
If you have any questions about this product, please contact us at [email protected], or visit www.tagridllc.com for more information.
Tested and designed in the USA.
Questions or comments?
Contact us at: [email protected]
Inactive Ingredient
Ingredients:
- GLEDITSIA SINENSIS FRUIT
- MENTHA CANADENSIS WH LE
- STELLERA CHAMAEJASME WHOLE
- OATMEAL
- SOPHORA FLAVESCENS ROOT
- PHELLODENDRON CHINENSE WHOLE
- CNIDIUM MONNIERI FRUIT
- STEMONA SESSILIFOLIA ROOT
- EUCALYPTUS GLOBULUS LEAF OIL
- DICTAMNUS DASYCARPUS ROOT BARK
- MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
- Borneol
- Sophora Flavescens Root
- Cnidium monnieri Root
- Bassia scoparia Fruit
- Scoparia Pollen
- Dictamnus Dasycarpus Root
- Smilax Glabra Whole
- Artemisia argyi Leaf
- Tea Tree Oil
Otc - Purpose
Antifungal Ointment
Otc - Pregnancy Or Breast Feeding
ask a healthcare provider before use.
Instructions For Use
- Clean the affected area thoroughly with soap and water and dry completely before applying the cream.
- Apply a small amount of ointment to the affected area and gently rub in.
- Use daily for up to 4 weeks, or as directed by a healthcare provider.
Package Label.Principal Display Panel
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