COLGATE ANTICAVITY KIT- sodium monofluorophosphate paste, dentifrice

Colgate Anticavity Kit by

Drug Labeling and Warnings

Colgate Anticavity Kit by is a Otc medication manufactured, distributed, or labeled by Ming Fai Industrial (Shenzhen) Co. Ltd, Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of the 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 physician
• children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
• children under 2 years: ask a dentist or physician

Inactive ingredients

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

Call toll-free 1-800-468-6502

Package Labeling:

INGREDIENTS AND APPEARANCE

COLGATE ANTICAVITY KIT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56153-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56153-002-05	1 in 1 PACKAGE	05/10/2013
1		5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 56153-002-10	1 in 1 PACKAGE	05/10/2013
2		10 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 final	part355	05/10/2013

Labeler - Ming Fai Industrial (Shenzhen) Co. Ltd (527078784)

Registrant - Ming Fai Industrial (Shenzhen) Co. Ltd (527078784)

Establishment
Name	Address	ID/FEI	Business Operations
Ming Fai Industrial (Shenzhen) Co. Ltd		527078784	manufacture(56153-002)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive Company		672044552	manufacture(56153-002)