INTERNATIONAL BUSINESS CLASS 1 KIT- sodium fluoride kit

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Disponible desde:

Buzz Products (HK) Co. Limited

Designación común internacional (DCI):

SODIUM FLUORIDE

Composición:

FLUORIDE ION 1.6 mg in 1 g

tipo de receta:

OTC DRUG

indicaciones terapéuticas:

helps protect against cavities

Estado de Autorización:

OTC monograph final

Ficha técnica

INTERNATIONAL BUSINESS CLASS 1 KIT- SODIUM FLUORIDE
BUZZ PRODUCTS (HK) CO. LIMITED
_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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INTERNATIONAL BUSINESS CLASS #1 KIT
_DRUG FACTS_
_ACTIVE INGREDIENT_
Sodium fluoride 0.243%
_PURPOSE_
Anticavity toothpaste
_USE_
helps protect against cavities
_WARNING_
KEEP OUT OF REACH OF CHILDREN UNDER 6 YRS. 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 yrs. & older: brush teeth thoroughly after meals
or at least
twice a day or use as directed by a dentist
do not swallow
to minimize swallowing use a pea-sized amount in children under 6
supervise children's brushing until good habits are established
children under 2 yrs.: ask a dentist
_INACTIVE INGREDIENTS_
glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6,
flavor, trisodium
phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine,
sodium
saccharin, PEG-20M or PEG-23M, xanthan gum, sucralose, mica, titanium
dioxide
_QUESTIONS?_
1-800-492-7378
PACKAGE LABELING
INTERNATIONAL BUSINESS CLASS 1 KIT
sodium fluoride kit
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:70402-013
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70402-013-
01
1 in 1 KIT; Type 0: Not a Combination
Product
04/30/2018
12/31/2021
QUANTITY OF PARTS
PART #
PACKAGE QUANTITY
TOTAL PRODUCT QUANTITY
PART 1
1 TUBE
24 g
PART 1 OF 1
CREST 3D WHITE BRILLIANCE
sodium fluoride paste, dentifrice
PRODUCT INFORMATION
ITEM CODE (SOURCE)
NDC:37000-873
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
FLUORIDE ION
1.6 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
GLYCERI