SIGNAL TRIPLE PROTECTION COMPLETE- sodium fluoride paste, dentifrice

Signal Triple Protection Complete by

Drug Labeling and Warnings

Signal Triple Protection Complete by is a Otc medication manufactured, distributed, or labeled by A.K. Rashidzada Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium Fluoride (0.24%) (0.15% W?V fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

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.

Directions

• Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor
• Children under 6 years of age: instruct in good brushing and rinsing habits (to minimize swallowing); supervise children as necessary until capable of using without supervision
• Children under 2 years of age: consult a dentist or doctor

Inactive ingredients

Sorbitol, water (aqua), hydrated silica, sodium lauryl sulfate, peg-32, fragrance, silica, cellulose gum, sodium saccharin, alumina, sodium sulfate, lauryl alcohol, sodium oxide,sodium chloride, magnesium oxide, calcium oxide, limonene, iron oxides, titanium dioxide.

Questions or comments?

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Package Labeling:

INGREDIENTS AND APPEARANCE

SIGNAL TRIPLE PROTECTION COMPLETE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73533-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM SULFATE (UNII: 0YPR65R21J)
LAURYL ALCOHOL (UNII: 178A96NLP2)
SODIUM OXIDE (UNII: 3075U8R23D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73533-122-18	1 in 1 BOX	03/01/2020
1		180 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/01/2020

Labeler - A.K. Rashidzada Corporation (155562408)