DELTA SKY CLUB- sodium monofluorophosphate kit

Delta Sky Club by

Drug Labeling and Warnings

Delta Sky Club by is a Otc medication manufactured, distributed, or labeled by Buzz Export Services Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Fact

Active ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of the reach of children under 6 years 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 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, aqua(water), sorbitol, sodium lauryl sulfate, aroma(flavour,) cellulose gum, tetrasodium pyrophosphate, sodium saccharinm limonene

Questions or comments?

Call to-free 1-800-468-6502

Package Labeling:

INGREDIENTS AND APPEARANCE

DELTA SKY CLUB 
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69491-101

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69491-101-00	1 in 1 KIT	01/01/2015

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	10 g

Part 1 of 1

COLGATE 
sodium fluoride paste

Product Information
Item Code (Source)	NDC: 69491-060
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69491-060-94	1 in 1 CARTON
1		10 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	part355	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355B	01/01/2015

Labeler - Buzz Export Services Pty Ltd (747317902)