TEND ANTICAVITY- sodium monofluorophosphate gel

Tend Anticavity by

Drug Labeling and Warnings

Tend Anticavity by is a Otc medication manufactured, distributed, or labeled by Tend, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

QUESTIONS

(888) 818-3686 www.hellotend.com

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

TEND ANTICAVITY 
sodium monofluorophosphate gel

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/2022

Labeler - Tend, LLC (117113952)