GUM- sodium fluoride paste, dentifrice Sunstar Americas, Inc. 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. ------Gum

Fluoride Toothpaste

DRUG FACTS: Active Ingredient Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

Purpose Anticavity

Use: helps in prevention of cavities.

Warnings:Keep out of reach of children under six year of age. if more than use for brushing is accidently 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 meals or at least twice a day, or use as directed by a dentist or a physician. To minimize swallowing for children under 6,use only pea-sized amount and supervise the child's brushing.

Children under 2 years of age ask a dentist or physician

Inactive Ingredients:Sorbitol, Silica, Purified Water, Glycerin, PEG-12, Sodium Lauryl Sulfate, Titanium Dioxide, Flavor, Cellulose, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin TWIST OFF CAP AND REMOVE FOIL SEAL. DONOT USE IF FOIL IS NOT INTACT.

Distributed by: Sunstar Americas, In. Chicago, IL 60630, U.S.A., Made in U.S.A. GUMbrand.com DOC02399 P13190

SUNSTAR G.U.M®CAVITY PROTECTION 1746 HEALTHY GUMS. HEALTHY LIFE® DOC02399 Fluoride Toothpaste P13190 0.85 oz/18 mL/Cont.net 24g

GUM sodium fluoride paste, dentifrice

Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:52376 -0 36 Route of Administration DENTAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O) FLUORIDE ION 0 .24 g in 10 0 g Inactive Ingredients Ingredient Name Strength SO RBITO L (UNII: 50 6 T6 0 A25R) SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) WATER (UNII: 0 59 QF0 KO0 R) GLYCERIN (UNII: PDC6 A3C0 OX) PO LYETHYLENE GLYCO L 6 0 0 (UNII: NL4J9 F21N9 ) SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J) TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311) SO DIUM BENZO ATE (UNII: OJ245FE5EU) SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74) SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

Product Characteristics Color white Score Shape Siz e Flavor MINT Imprint Code Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52376 -0 36 -0 2 24 g in 1 TUBE

Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph final part355 12/0 1/20 13

Labeler - Sunstar Americas, Inc. (025066358)

Revised: 11/2013 Sunstar Americas, Inc.