DELTA RON 2019 AMENITY WITH COLGATE CAVITY PROTECTION- sodium monofluorophosphate, aluminum zirconium tetrachlorohydrex gly kit

DELTA RON 2019 AMENITY With Colgate Cavity Protection by

Drug Labeling and Warnings

DELTA RON 2019 AMENITY With Colgate Cavity Protection 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 Facts

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 apea 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?

1-800-492-7378

Drug Facts

Active ingredient

Aluminum Zirconium Tetrachlorohydrex GLY (15.2%)

Purpose

anti-perspirant

Uses

• Reduces Underarm Wetness
• 48 Hour Protection

Warnings

For external use only

Do not use

on broken skin

Ask a doctor before use

if you have kidney disease.

Stop use

if rash or irritation occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply to underarms only

Inactive ingredients

Cyclopentasiloxane, Stearyl Alcohol, C12-15 Alkyl Benzoate, PPG-14 Butyl Ether, Hydrogenated Castor Oil, PEG-8, Fragrance (Parfum), Dimethicone, Silica, Polyethylene, Helianthus Annuus (Sunflower) Seed Oil, Steareth-100, BHT, Hydroxyethyl Urea

Questions or comments?

Call toll free 1-800-761-3683

DELTA RON KIT 2019 - AMENITY KIT With Colgate Cavity Protection Toothpaste (

69491-215-00)

COLGATE ANTICAVITY 10g (

42555-060-45)

DOVE ADVANCED CARE COOL ESSENTIALS ANTIPERSPIRANT AND DEODORANT 14 g (

64942-1343-2)

INGREDIENTS AND APPEARANCE

DELTA RON 2019 AMENITY WITH COLGATE CAVITY PROTECTION 
sodium monofluorophosphate, aluminum zirconium tetrachlorohydrex gly kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69491-215

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69491-215-00	1 in 1 KIT	04/01/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	10 g
Part 2	1 TUBE	14 g

Part 1 of 2

COLGATE ANTICAVITY 
sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC: 42555-060
Route of Administration	DENTAL

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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42555-060-45	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	04/01/2019

Part 2 of 2

DOVE  ADVANCED CARE COOL ESSENTIALS ANTIPERSPIRANT AND DEODORANT
aluminum zirconium tetrachlorohydrex gly stick

Product Information
Item Code (Source)	NDC: 64942-1343
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE)	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY	15.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PPG-14 BUTYL ETHER (UNII: R199TJT95T)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SUNFLOWER OIL (UNII: 3W1JG795YI)
STEARETH-100 (UNII: 4OH5W9UM87)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64942-1343-2	14 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	part350	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/01/2019

Labeler - Buzz Export Services Pty., Ltd. (747317902)