COLGATE- sodium fluoride paste

Colgate by

Drug Labeling and Warnings

Colgate by is a Otc medication manufactured, distributed, or labeled by Buzz Export Services Pty., Ltd., Zhejiang Baron Travel Product Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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, glycerin, sodium lauryl sulfate, cellulose gum, flavor, tetrasodium pyrophosphate, sodium saccharin

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022

DRUG FACTS PANEL INSERT

DENTAL KIT - COLGATE TOOTHPASTE 5g Labels

TUBE LABELING:

KIT PACKAGING:

DENTAL KIT - COLGATE TOOTHPASTE 10g

TUBE LABELING:

KIT PACKAGING:

INGREDIENTS AND APPEARANCE

COLGATE 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69491-060
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 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)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69491-060-45	1 in 1 BAG	12/03/2014
1		5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69491-060-94	1 in 1 CARTON	12/03/2014
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	12/03/2014

Labeler - Buzz Export Services Pty., Ltd. (747317902)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.		421290194	repack(69491-060)