Label: CRAYOLA ANTICAVITY STRAWBERRY FLAVOR- sodium fluoride paste, dentifrice
- NDC Code(s): 70108-080-01
- Packager: Ashtel Studios, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated September 11, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
• Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
• Do not swallow.
• Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
• Children under 2 years of age: Consult a dentist or doctor. - Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
BrushBuddies®
Silly scents
HELPS PREVENT CAVITIES
STRAWBERRY FLAVOR
CAUTION:
AVOID EXCESSIVE INGESTION.
NOT FOR PETS.
NOT TESTED ON ANIMALS.OFFICIAL LICENSED PRODUCT
DESIGNED IN U.S.A. • MADE IN INDIA
QUALITY GUARANTEE
Ashtel Studios Inc. guarantees the quality of this Crayola product. If this product does not perform properly, please contact us at 1-877-274-8358, Monday-Friday 8AM-5PM. PST
ABOUT US
Crayola A Hallmark Company
©2023 CRAYOLA, EASTON, PA 18044-0431.
CrayolaTM, Silly ScentsTM and Chevron DesignTM are trademarks of Crayola used under license.
make brushing fun!®
WWW.BRUSHBUDDIES.COM
• 1-909-434-0911 INTERNATIONAL
DISTRIBUTED BY ASHTEL STUDIOS INC., • ONTARIO, CALIFORNIA 91761
PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE
- Packaging
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INGREDIENTS AND APPEARANCE
CRAYOLA ANTICAVITY STRAWBERRY FLAVOR
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70108-080 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.243 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A) XYLITOL (UNII: VCQ006KQ1E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color pink Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70108-080-01 1 in 1 BOX 09/06/2023 1 113 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 M021 09/06/2023 Labeler - Ashtel Studios, Inc. (148689180)
