RON 2- sodium monofluorophosphate, aluminum zirconium tetrachlorohydrex gly 
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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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RON Kit 2

COLGATE TOOTHPASTE

Drug Facts

Active ingredient

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

Purpose

Anticavity

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(flavor), cellulose gum, tetrasodium pyrophosphate, sodium saccharin, limonene

Questions or comments?

Call toll-free 1-800-468-6502

Dove advanced care cool essentials anti-perspirant deodorant

Drug Facts

Active ingredient

Aluminum Zirconium Tetrachlorohydrex GLY (15.2%)

Purpose

anti-perspirant

Uses

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

Package Labeling:

product label

drug facts panel

Package Labeling:

frontbooklet

RON 2 
sodium monofluorophosphate, aluminum zirconium tetrachlorohydrex gly kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69491-030
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69491-030-001 in 1 BAG; Type 1: Convenience Kit of Co-Package03/30/2015
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 10 g
Part 21 TUBE 14 g
Part 1 of 2
COLGATE ANTICAVITY 
sodium monofluorophosphate paste, dentifrice
Product Information
Item Code (Source)NDC:42555-060
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42555-060-4510 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/30/2015
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE) ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY15.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64942-1343-314 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35003/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/30/2015
Labeler - Buzz Export Services Pty., Ltd. (747317902)

Revised: 12/2021
Document Id: d421f377-ef12-73c4-e053-2a95a90a8b0e
Set id: 7430a8fb-9301-4449-bedc-8c8f21c43bb1
Version: 7
Effective Time: 20211227
 
Buzz Export Services Pty., Ltd.