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Drug Facts
MADE WITH PRIDE AND CARE FOR H-E-B®
SAN ANTONIO, TX 78204
Heb
FDA Label NDC 37808-896
11 label sections · Submitted to the FDA by Heb · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Heb for the product Heb (NDC 37808-896). 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 - keep out of reach of children, dosage & administration, inactive ingredient, 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 Monofluorophosphate 0.76% w/w (0.15% w/v fluoride ion)
Otc - Purpose
Purpose
Anticavity
Indications & Usage
Uses aids in the prevention of dental caviites
Warnings
Warnings
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice per day, or as directed by a dentist or doctor.
- Instruct children under 6 years of age in good brushing and rinsing habits (to avoid swallowing).
- Supervise children as necessary until capable of using without supervision.
- Children under 2 years of age: consult a dentist or doctor.
Inactive Ingredient
Inactive ingredients glycerin, dicalcium phosphate, propylene glycol, PEG-12, PVP, silica, PEG/PPG 116/66 copolymer, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, hydrogen peroxide, etidronic acid, butylated hydroxytoluene, sodium saccharin, sucralose, phosphoric acid, water
Storage And Handling
Store in a cool dry place. Keep tube capped when not in use.
Otc - Questions
Questions or comments? CALL 1-877-777-2743
Package Label.Principal Display Panel
H-E-B®
Dazzling Mint
BRILLIANT WHITE
FLUORIDE ANTICAVITY TOOTHPASTE
NET WT. 5 OZ (141.7 g)
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