Universal Charcoal With Aloe Vera Anti-cavity Fluoride Paste
FDA Label NDC 52000-110

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Universal Charcoal With Aloe Vera Anti-cavity Fluoride (NDC 52000-110). 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 - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Sodium Fluoride-0.32% (0.15% w/v fluride ion)

Otc - Purpose

Purpose

Anticavity

Indications & Usage

Uses

  • builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets
  • aids in the prevention of dental cavities.

Warnings

Warning

Otc - When Using

When using this product

  • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.

Otc - Stop Use

Stop and ask a dentist

  • if the problem persists or worsens.

    • Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

  • If accidentally swallowed while brushing, seek professional help or contact a Poison Control Center immediately.

Dosage & Administration

Directions

  • adults and children 12 years of age and older
  • apply atleast 1-inch strip of product onto soft bristle toothbrush
  • brush teeth thoroughly for atleast 1 minute twice a day (morning and evening), and not more then 3 times a day, or as recommended by a dentist or doctor.
  • Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

    • Children under 12 years of age: Consult a dentist or doctor

Other

Other information

  • store in a cool, dry place.

Inactive Ingredient

Inactive Ingredients

Sorbitol, Silica, Xanthan gum, Sodium saccharine, Sodium benzoate, Sodium Lauryl sulphate, Water, Flavor, Charcoal powder, poly ethylene glycol 1500, Aloe vera.

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE TOOTHPASTE

Label (Charcoal With Aloevera)

Label (Charcoal With Aloevera)

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