Colgate Co Oh So Glowing: Package Insert and Label Information

COLGATE CO OH SO GLOWING- stannous fluoride gel, dentifrice
Colgate-Palmolive Company

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.

Drug Facts

Active ingredient

Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

Anticavity, Antigingivitis, Antisensitivity

Uses

• aids in the prevention of cavities
• helps prevent gingivitis
• helps interfere with harmful effects of plaque associated with gingivitis
• builds increasing protection against painful sensitivity of the teeth to cold, heat, acid, sweets, or contact

Warnings

• When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist.

• Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

• Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

• Stop use and ask a dentist if
  • gingivitis, bleeding or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between the teeth. These may be signs of periodontis, a serious form of gum disease.

Directions

• Adults and children 12 years of age and older: apply at least a 1-inch stip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
• Do not swallow.
• Children under 12 years of age: consult a dentist.

Other Information

• products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
• this Colgate product is specially formulated to help prevent staining.

Inactive ingredients

Sorbitol, Water, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Tetrasodium Pyrophosphate, Potassium Nitrate, Xanthan Gum, Sodium Saccharin, Cocamidopropyl Betaine, Charcoal Powder, Blue 1.

Questions?

1-855-658-0289

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

PRINCIPAL DISPLAY PANEL — 99 g Tube Carton

CO.
by Colgate^®

Oh So
Glowing
Gel Toothpaste

With Charcoal

Gentle + Effective Whitening

Forever Mint

Anticavity, Antigingivitis and
Antisensitivity Toothpaste

NET WT 3.5 OZ (99 g)

COLGATE CO OH SO GLOWING stannous fluoride gel, dentifrice

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-136 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.1 mg in 1 g

Inactive Ingredients Ingredient Name Strength SORBITOL WATER HYDRATED SILICA POLYETHYLENE GLYCOL 600 SODIUM LAURYL SULFATE SODIUM PYROPHOSPHATE POTASSIUM NITRATE XANTHAN GUM SACCHARIN SODIUM COCAMIDOPROPYL BETAINE ACTIVATED CHARCOAL FD&C BLUE NO. 1

Product Characteristics Color BLACK Score Shape Size Flavor MINT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:35000-136-68 1 TUBE in 1 CARTON contains a TUBE 1 99 g in 1 TUBE This package is contained within the CARTON (35000-136-68)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 01/10/2022 01/31/2024

Labeler — Colgate-Palmolive Company (001344381)

Revised: 08/2022 Colgate-Palmolive Company