Otc - Active Ingredient
TEA TREE OIL、UNDECYLENIC ACID、EUCALYPTUS GLOBULUS LEAF、MENTHA PIPERITA LEAF、LICORICE ROOT EXTRACT、ALLANTOIN、PANTHENOL、ALOE VERA LEAF、CHAMOMILE/MATRICARIA、LAVENDER OIL
Putrizen Tea Tree Oil Antifungal Cream
FDA Label NDC 84983-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shantou South Moon Biotechnology Co., Ltd. for the product Putrizen Tea Tree Oil Antifungal Cream (NDC 84983-030). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - when using, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Helps prevent most athlete's foot with daily use. For effective relief of itching, burning and cracking.
Otc - When Using
1, clean the affected area with soap and water, then dry thoroughly.
2. Apply a thin layer to the affected area twice daily(morning and night).
3. Use daily as part ofyour routine for up to 4 weeks. if the issue persists beyond this time, consult a doctor.
Warnings
For external use only."Do not use if seal under cap is broken or missing."Close the lid tightly after use.Do not use this product if you are allergic to any of its ingredients.Do not use on children under 2 years of age unless directed by a doctor. Ask a doctor before use if you have Diabetes.When using this productAvoid contact with the eyes. Stop use and ask a doctor if- Irritation occurs There is no improvement within 4 weeks.If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Do Not Use
Do not use if seal under cap is broken or missing."Close the lid tightly after use.Do not use this product if you are allergic to any of its ingredients.Do not use on children under 2 years of age unless directed by a doctor.
Otc - Stop Use
Stop use and ask a doctor if- Irritation occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Storage And Handling
Store at 200-25°c(68°-77°F) away from direct sunlight and heat
Inactive Ingredient
WATER、GLYCERIN、MINERAL OIL、GLYCERYL、MONOSTEARATE、1,2-HEXANEDIOL、CARBOMER、HOMOPOLYMER TYPE A、TROLAMINE
Indications & Usage
1., clean the affected area with soap and water, then dry thoroughly.
2. Apply a thin layer to the affected area twice daily(morning and night).
3. Use daily as part ofyour routine for up to 4 weeks. if the issue persists beyond this time, consult a doctor.
Dosage & Administration
1., clean the affected area with soap and water, then dry thoroughly.
2. Apply a thin layer to the affected area twice daily(morning and night).
3. Use daily as part ofyour routine for up to 4 weeks. if the issue persists beyond this time, consult a doctor.
Package Label.Principal Display Panel
Label (Dsku 00001378)
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