OTC Medication Information: Crest Pro-Health Advanced

CREST PRO-HEALTH ADVANCED- stannous fluoride paste, dentifrice
The Procter & Gamble Manufacturing 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% (0.16% w/v fluoride ion)

Purposes

Anticavity, antigingivitis, antisensitivity toothpaste

Uses

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

Warnings

When using this product do not use for sensitivity longer than four 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.

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.

Directions

• adults and children 12 yrs. & older: apply at least a 1-inch strip of the product onto a soft bristle 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 yrs.: ask 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 Crest is specially formulated to help prevent staining
• see your dentist regularly

Inactive ingredients

glycerin, hydrated silica, sodium hexametaphosphate, propylene glycol, PEG-6, water, zinc lactate, trisodium phosphate, flavor, sodium lauryl sulfate, sodium gluconate, carrageenan, sodium saccharin, xanthan gum, mica, titanium dioxide, blue 1

Questions?

1-800-594-4158

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL — 99 g Tube Carton

DEEP CLEANING FORMULA

Crest ^® PRO-HEALTH ™

ADVANCED

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

WHITENING POWER

CAVITIES | GINGIVITIS | ACID EROSION** | SENSITIVITY PLAQUE | TARTAR | WHITENING | FRESHENS BREATH

NET WT 3.5 OZ (99 g)

CREST PRO-HEALTH ADVANCED stannous fluoride paste, dentifrice

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-892 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.6 mg in 1 g

Inactive Ingredients Ingredient Name Strength ZINC LACTATE GLYCERIN HYDRATED SILICA SODIUM POLYMETAPHOSPHATE PROPYLENE GLYCOL POLYETHYLENE GLYCOL 300 WATER SODIUM LAURYL SULFATE SODIUM GLUCONATE CARRAGEENAN SACCHARIN SODIUM XANTHAN GUM TITANIUM DIOXIDE SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS FD&C BLUE NO. 1 MICA

Product Characteristics Color blue Score Shape Size Flavor WINTERGREEN Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:37000-892-01 1 TUBE in 1 CARTON contains a TUBE 1 24 g in 1 TUBE This package is contained within the CARTON (37000-892-01) 2 NDC:37000-892-03 1 TUBE in 1 CARTON contains a TUBE 2 99 g in 1 TUBE This package is contained within the CARTON (37000-892-03) 3 NDC:37000-892-05 1 TUBE in 1 CARTON contains a TUBE 3 144 g in 1 TUBE This package is contained within the CARTON (37000-892-05) 4 NDC:37000-892-07 2 CARTON in 1 CELLO PACK contains a CARTON 4 1 TUBE in 1 CARTON This package is contained within the CELLO PACK (37000-892-07) and contains a TUBE 4 99 g in 1 TUBE This package is contained within a CARTON and a CELLO PACK (37000-892-07) 5 NDC:37000-892-10 2 CARTON in 1 CELLO PACK contains a CARTON 5 1 TUBE in 1 CARTON This package is contained within the CELLO PACK (37000-892-10) and contains a TUBE 5 144 g in 1 TUBE This package is contained within a CARTON and a CELLO PACK (37000-892-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 12/29/2016

Labeler — The Procter & Gamble Manufacturing Company (004238200)

Revised: 05/2023 The Procter & Gamble Manufacturing Company