Otc - Active Ingredient
Active ingredients: Sodium monofluorophosphate 0.21g/30g
Anti Caries
FDA Label NDC 84518-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fujian Youxi Sanmiao Trading Co., Ltd. for the product Anti Caries (NDC 84518-005). 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, dosage & administration, inactive ingredient, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Toothpaste for protecting teeth
Indications & Usage
1. Prevent tooth decay: During the brushing process, fluoride can be attached to the surface of the teeth to form a protective layer to prevent bacterial erosion.
2. Clean dental plaque: Fluoride has a redox effect, which can make the dental plaque attached to the surface of the teeth fall off.
Warnings
Warnings section
For external use only. Keep out of reach of children. Avoidcontact with eyes. Discontinue use if signs of irritation or rash occur.
Dosage & Administration
Dosage & administration section
Squeeze an appropriate amount of paste onto a toothbrush and gently scrub teeth and tongue for 2-3 minutes to leave them clean and refreshed.
Inactive Ingredient
INACTIVE INGREDIENTS:
GLYCERIN, AQuA, HYDRATED SILICA, POLYSORBATE S0, CELLULOSE GUM,MENTHAPIPERITA(PEPPERMINT) OL, PHENOXYETHANOL, sUCRALOSE, TETRASODUMPYROPHOSPHATE, CI17200/D&C RED NO.33, C1 42090/FD&C BLUE NO.1, ETHYLHEXYLGLYCERIN.
Otc - Keep Out Of Reach Of Children
For external use only. Keep out of reach of children. Avoidcontact with eyes. Discontinue use if signs of irritation or rash occur.
Package Label.Principal Display Panel
Anti-caries Toothpaste (Label)
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