Plus White Extra Whitening
FDA Label NDC 61543-1606

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cca Industries, Inc. for the product Plus White Extra Whitening (NDC 61543-1606). 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 active ingredient, purpose, uses, warnings, directions, inactive ingredient, otc - questions, principal display panel -tube 3.5 oz, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient



Sodium Monofluorophosphate 0.83%  (0.11% w/v fluoride ion)                           

Purpose

Anticavity Toothpaste

Uses

 Aids in the prevention of dental cavitites.

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  •  Adults and children 2 years and older
  •  Brush teeth thoroughly, after each meal, or at least twice a day, or as directed by a dentist or physician
  • instruct under 6 years of age in good brushing and rinse habits (it minimizes swallowing), and only use a pea size amount.
  • Children under 2 years ask a dentist or physician

Inactive Ingredient

Inactive ingredients Sorbitol, Hydrated Silica, Glycerin, Water (Purified), PEG 32, Flavor, Sodium lauryl Sulfate, PVM/MA Copolymer, Flavor, Cellulose Gum, Trisodium Phosphate, Sodium Phosphate, Sodium Saccharin, Blue 1, yellow 10

Otc - Questions

Questions or comments? Call Toll Free1-800-595-6230
- www.pluswhite.com

Principal Display Panel -Tube 3.5 Oz

Plus+White
Extra Whitening Gel TOOTHPASTE

Net Wt 3.5 oz (100G) - Fluoride Anticavity Toothpaste

Principal Display Panel - Carton 3.5 Oz

Plus + White 

Extra Whitening Gel Toothpaste 

NET WT 3.5 oz (100G) Fluoride Anticavity Toothpaste 

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