Denblan
FDA Label NDC 16555-996

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Darphin Dist. for the product Denblan (NDC 16555-996). 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, active ingredient, purpose, use, otc - keep out of reach of children, otc - when using, directions, ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DARPHIN
LABORATORIES DARPHIN, Dist.

Active Ingredient

Sodium monofluorophosphate 0.76%

Purpose

Fluoride toothpaste

Use

Aids in the prevention of dental cavities.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age.

Otc - When Using

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 of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as neccessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

Ingredients

water, dicalcium phosphate, calcium carbonate, silica, glycerin, sorbitol, algin, carica papaya (papaya) fruit extract, ananas sativus (pineapple) fruit extract, mentha viridis (spearmint) leaf oil, mentha arvensis leaf oil, usnea barbata (lichen) extract, angelica archangelica root oil, carum petroselinum (parsley) seed oil, foeniculum vulgare (fennel) oil, sodium lauryl sulfate, propylene glycol, sodium saccharin, limonene, sodium benzoate, sodium propylparaben, sodium methylparaben <ILN36886>.

Principal Display Panel - 75Ml Carton

WHITENING FORMULA
DENBLAN
ANTICAVITY FLUORIDE TOOTHPASTE

REFRESHING MINT TASTE

e 75mL
POIDS NET WT. 2.6 OZ.

Principal Display Panel (75mL Carton)

Principal Display Panel (75mL Carton)

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