Colgate® Baking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint® Fluoride Toothpaste

Colgate by

Drug Labeling and Warnings

Colgate by is a Otc medication manufactured, distributed, or labeled by Mission Hills S.A de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE  BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT- sodium monofluorophosphate paste, dentifrice 
Mission Hills S.A de C.V
Reference Label Set Id: ef4461e1-f021-4604-b9e0-76dbce1f0c25

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® Baking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint® Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.14% 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

glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide, FD&C blue no. 1, D&C yellow no. 10

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 232 g Tube Label

Colgate®
Fluoride Toothpaste

NET WT 8.2 OZ (232 g)

Baking Soda
& Peroxide
Whitening

Cleans Deep and
Whitens Teeth

Frosty Mint®Stripe Gel

COLGATE   BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-768
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.0 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	491.6 mg  in 1 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN, WHITE	Score
Shape		Size
Flavor	SPEARMINT, PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65954-768-69	1 in 1 CARTON	08/20/2011
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 65954-768-64	1 in 1 CARTON	08/20/2011
2		181 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 65954-768-82	1 in 1 CARTON	08/20/2011
3		232 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 65954-768-60	1 in 1 CARTON	08/20/2011
4		170 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	08/20/2011

Labeler - Mission Hills S.A de C.V (812312122)

Revised: 4/2019

Document Id: adefaf26-26a0-4cef-8a79-898cbd661db3

34390-5

Set id: d8aad36d-5537-4eaf-b9a3-75a9919f4d6e

Version: 4

Effective Time: 20190429