White Glo Charcoal Sensitive Kit
FDA Label NDC 73656-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by White Glo Usa Inc for the product White Glo Charcoal Sensitive (NDC 73656-011). 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 drug facts, active ingredients, purpose, uses, when using this product,, stop use and ask a dentist if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Potassium nitrate 5%
Sodium monofluorophospahte 0.76% (0.1% w/v fluoride ion)
Purpose
Antihypersensitivity
Anticavity
Uses
• Builds increasing protection against: painful sensitivity of the teeth to cold, heat, acids, sweets or contact.
• Aids in the prevention of dental cavities.
When Using This Product,
if irritation occurs discontinue use.
Stop Use And Ask A Dentist If
• the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
• pain/sensitivity still persists after 4 weeks of use.
Keep Out Of Reach Of Children.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
• adults and children 12 years of age and older:
• apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
• brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by 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 Information
• store below 30°C (86°F)
Inactive Ingredients
Sorbitol, hydrated silica, sodium lauryl sulfate, glycerin, water, cellulose gum, chondrus crispus (carrageenan), tetrasodium phosphate, sodium saccharin, sodium benzoate, bamboo charcoal
Questions Or Comments?
For customer enquiries, please contact: [email protected] White Glo USA INC. 25 Suffolk Court, Hauppauge, NY, 11788 USA. www.whiteglo.com
Package Labeling:
Label (Label)
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