Revitealize
FDA Label NDC 54866-000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Camellix, Llc for the product Revitealize (NDC 54866-000). 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, indications & usage, warnings, otc - keep out of reach of children, otc - ask doctor, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients:

Salicylic Acid 1.8%

Otc - Purpose

Purpose: 

Help Control of flaking and itching associated with dandruff and scalp psoriasis

Indications & Usage

Uses:

For relief of itching and scalp flaking associated with dandruff, seborrheic dermatitis and psoriasis.

Warnings

Warnings:

  • For external use only.

Otc - Keep Out Of Reach Of Children

Keep out of reach of small children. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Otc - Ask Doctor

If swallowed, get medical help or contact a Poison Control Center immediately. If condition worsens or does not improve after regular use of this product as directed, consult a doctor.




Dosage & Administration

DirectionsFor best control of dandruff, use every time you shampoo. Wet hair, massage shampoo onto scalp, wait for at least 2 minutes, rinse, repeat if necessary. For best results use at least twice a week or as directed by a doctor

Inactive Ingredient


Inactive Ingredients
Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Stach Hydroxypropyltrimonium Chloride, Glycerol Laurate, Green Tea Leaf Extract, SD Alcohol 40 (Alcohol Denatured), Aloe barbadensis Leaf Juice, Polysorbate 20, Glycerin, Panthenol, Retinyl Palmitate, Cholecalciferol, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Zea Mays (Corn) Oil, Tetrasodium EDTA, DMDM Hydantoin.





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