UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE- sodium fluoride paste

UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE by

Drug Labeling and Warnings

UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Sodium Fluoride-0.32% (0.15% w/v fluride ion)

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Uses

• builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets
• aids in the prevention of dental cavities.

WARNINGS

Warning

WHEN USING

When using this product

• if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.

STOP USE

Stop and ask a dentist

• if the problem persists or worsens.

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

• If accidentally swallowed while brushing, seek professional help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• adults and children 12 years of age and older
• apply atleast 1-inch strip of product onto soft bristle toothbrush
• brush teeth thoroughly for atleast 1 minute twice a day (morning and evening), and not more then 3 times a day, or as recommended by a dentist or doctor.
• Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

Children under 12 years of age: Consult a dentist or doctor

SPL UNCLASSIFIED SECTION

Other information

• store in a cool, dry place.

INACTIVE INGREDIENT

Inactive Ingredients

Sorbitol, Silica, Xanthan gum, Sodium saccharine, Sodium benzoate, Sodium Lauryl sulphate, Water, Flavor, Charcoal powder, poly ethylene glycol 1500, Aloe vera.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE TOOTHPASTE

INGREDIENTS AND APPEARANCE

UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-110
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-110-01	122 g in 1 TUBE; Type 0: Not a Combination Product	05/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	05/25/2020

Labeler - Universal Distribution Center LLC (019180459)