Colgate Anticavity Toothpaste

Colgate Anticavity by

Drug Labeling and Warnings

Colgate Anticavity by is a Otc medication manufactured, distributed, or labeled by Luoding Quality Amenities Supply Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE ANTICAVITY- sodium monofluorophosphate paste 
Luoding Quality Amenities Supply Limited

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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Colgate Anticavity Toothpaste

Drug Facts

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:72135-032-01

COLGATE ANTICAVITY 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72135-032
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72135-032-01	10 g in 1 TUBE; Type 0: Not a Combination Product	10/12/2020	09/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/12/2020	09/30/2023

Labeler - Luoding Quality Amenities Supply Limited (528126807)

Revised: 9/2023

Document Id: 0685f812-fa03-815a-e063-6294a90acbae

34390-5

Set id: b0779880-b705-1197-e053-2995a90a2f45

Version: 2

Effective Time: 20230929