TEND ANTICAVITY- sodium monofluorophosphate gel
Tend, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Tend Enjoymint Anticavity toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children

under 6 years of age.If you swallow more than a pea-sized dollop, get medical help or contact a poison control center right away.

Directions

Adults and children 6 years of age and older: our dentists recommend applying a pea-sized dollop of toothpaste on a soft-bristled toothbrush. Brush teeth thoroughly for 2 minutes twice a day, and not more than 3 times a day, or as recommended by your dentist or hysician. Minimize swallowing.
Children under 6 years of age: consult a dentist or physician.

Inactive ingredients

glycerin, water, calcium carbonate, hydrated silica, hydroxyapatite, xanthan gum, flavor, sodium lauroyl sarcosinate, benzyl alcohol, sodium bicarbonate

(888) 818-3686 www.hellotend.com

Package Labeling:

Outer Package Inner Package

Package Labeling:

Label2

TEND ANTICAVITY
sodium monofluorophosphate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78594-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.3 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78594-000-01	1 in 1 CARTON	01/01/2022
1		96 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:78594-000-02	0.8 g in 1 TUBE; Type 1: Convenience Kit of Co-Package	01/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/01/2022

Labeler - Tend, LLC (117113952)