The following Structured Product Label (SPL) was submitted to the FDA by Moon Oral Care, Llc for the product Moon Whitening Anticavity (NDC 82214-002). 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 dosage & administration, warnings, indications & usage, otc - active ingredient, otc - purpose, otc - keep out of reach of children, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Directions:
Adults and children 2 years and older:
Brush teeth thoroughly after meals or at least twice a a day or use as direfted by a dentist
Do not swallow to minimize swallowing use a pea-sized amount in children under 6
Supervise children's brushing until good habits are established
Children under 2 years: ask a dentist
Warning:
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. Contains sodium fluoride. Children of 6 years and younger: Use a pea-sized amount with supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.
Children of 6 years and younger: Use a pea-sized amount with supervised brushing to minimize swallowing.
Sodium Fluoride 0.24% (0.13% w/v fluoride ion) Anticavity
Use: Aids in the prevention of dental cavities
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.
WATER
SORBITOL
HYDRATED SILICA
GLYCERIN
XYLITOL
MICA
CELLULOSE GUM
SODIUM LAUROYL SARCOSINATE
TITANIUM DIOXIDE
SACCHARIN SODIUM
CARRAGEENAN
FLAVOR
MENTHA ARVENSIS LEAF OIL
PEPPERMINT OIL
COCONUT OIL
CRANBERRY SEED OIL
TEA TREE OIL
SEA SALT
GREEN TEA LEAF
ECHINACEA ANGUSTIFOLIA LEAF
MYRCIARIA DUBIA FRUIT
ASIAN GINSENG
HYDROGEN PEROXIDE
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