Representative Package Label For Sent From Earth Ketoconazole 1% Anti Dandruff Shampoo, Ndc 87992-001-01.
Representative package label for Sent From Earth Ketoconazole 1% Anti Dandruff Shampoo, NDC 87992-001-01.
Sent From Earth Vita Scalp Revive Shampoo
FDA Label NDC 87992-002
9 label sections · Submitted to the FDA by Sent From Earth · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sent From Earth for the product Sent From Earth Vita Scalp Revive (NDC 87992-002). 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 representative package label for sent from earth ketoconazole 1% anti dandruff shampoo, ndc 87992-001-01., indications & usage, otc - purpose, otc - keep out of reach of children, warnings, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
| Active ingredient | Purpose |
| Ketoconazole 1% | Anti-dandruff |
Uses
controls flaking, scaling and itching associated with dandruff
Otc - Purpose
Anti-dandruff
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Warnings
Warnings
For external use only
Do not use
• on scalp that is broken or inflamed
• if you are allergic to ingredients in this product
When using this product
• avoid contact with eyes
• if product gets into eyes, rinse thoroughly with water
Stop use and ask a doctor if
• rash appears
• condition worsens or does not improve in 2-4 weeks
If pregnant or breast-feeding, ask a doctor before use.
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
adult and children 12 years and over
• wet hair thoroughly
• apply shampoo, generously lather, rinse thoroughly. Repeat
• use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed
children under 12 years
• ask a doctor
Storage And Handling
• store between 68° and 77°F (20° and 25°C)
• protect from light • protect from freezing
Inactive Ingredient
Water (Aqua), Sodium Cocoyl Isethionate, Potassium Cocoate, Propylene Glycol, Cocamidopropyl Betaine, Decyl Glucoside, Xanthan Gum, Citric Acid, Sodium PCA, Caffeine, Mentha Piperita (Peppermint) Leaf Oil, Niacinamide, Serenoa Serrulata Fruit Powder, Polyquaternium-7, Hydrolyzed Wheat Protein, Macadamia Ternifolia Seed Oil, Biotin (Vitamin B7), Panthenol (Provitamin B5), Persea Gratissima (Avocado) Oil, Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Leuconostoc/Radish Root Ferment Filtrate, Guar Hydroxypropyltrimonium Chloride, Sodium Benzoate, Potassium Sorbate
Otc - Questions
website: www.sentfromearth.com
email: [email protected]
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