UNITED AIRLINES BUSINESS CLASS KIT- sodium monofluorophosphate paste, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

United Airlines

INN (International Name):

SODIUM MONOFLUOROPHOSPHATE

Composition:

FLUORIDE ION 7.6 mg in 1 g

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anticavity helps protect against cavities

Authorization status:

OTC monograph final

Summary of Product characteristics

UNITED AIRLINES BUSINESS CLASS KIT- SODIUM MONOFLUOROPHOSPHATE PASTE,
DENTIFRICE
UNITED AIRLINES
----------
UNITED AIRLINES BUSINESS CLASS KIT
ACTIVE INGREDIENT
Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)
PURPOSE
Anticavity
USE
helps protect against cavities
WARNINGS
If more than used for brushing is accidentally swallowed, get medical
help or contact a
Poison Control Center right away. KEEP OUT OF THE REACH OF CHILDREN
UNDER 6
YEARS OF AGE.
DIRECTIONS
adults and children
2 years of age and
older
brush teeth thoroughly, preferably after each
meal or at least twice a day, or as directed by
a dentist or physician
children 2 to 6
years
use only a pea sized amount and supervise
child's brushing and rinsing (to minimize
swallowing)
children under 2
years
ask a dentist or physician
INACTIVE INGREDIENTS
dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate,
flavor, cellulose
gum, tetrasodium pyrophosphate, sodium saccharin
QUESTIONS OR COMMENTS?
Call toll-free 1-800-468-6502
PACKAGE LABELING:
UNITED AIRLINES BUSINESS CLASS KIT
sodium monofluorophosphate paste, dentifrice
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:58733-001
ROUTE OF ADMINISTRATION
DENTAL
United Airlines
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION -
UNII:Q80VPU408O)
FLUORIDE ION
7.6 mg
in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:58733-001-
10
1 in 1 PACKAGE
05/10/2013
1
10 g in 1 TUBE; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETIN