Elementz
FDA Label NDC 51870-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Keefe Group for the product Elementz (NDC 51870-007). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Indications & Usage

Uses

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

Warnings

For external use only.

Otc - When Using

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

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.

Dosage & Administration

Directions

  • Wet hair, massage shampoo into scalp
  • rinse and repeat if desired.
  • for maximum dandruff control, use at least twice a week or as directed by a doctor

Inactive Ingredient

Inactive ingredients Water, Sodium Laureth Sulfate, Cocamide DEA, Sodium Chloride, Styrene/Acrylates Copolymer, Coco-Glucoside, Polyquaternium-7, Fragrance, Tetrasodium EDTA, Magnesium Nitrate, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium Chloride, Citric Acid, Shea Butter, Sweet Almond Oil.

Package Label.Principal Display Panel

ELEMENTZ™

WITH MOISTURIZING ALMOND OIL & SHEA BUTTER

PYRITHIONE ZINC

DANDRUFF SHAMPOO

FOR DRY & ITCHY SCALP

15 FL OZ | 443 mL

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