Orbitol Whitening

Drug Labeling and Warnings

Drug Details [pdf]

ORBITOL WHITENING- sodium fluoride mouthwash 
COSMOPHARM LTD

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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Orbitol Whitening

Active Ingredients

Sodium Fluoride 0.15% (678 PPM Fluoride Ion)

Purpose

Anticavity

Uses

• Aids in the prevention of dental cavities
  

Warnings

Stop use and ask a dentist

if oral irritation or tooth sensitivity occurs.

Keep out of reach of children.

If more that used for rinsing is accidentally swallowed, get medical help or contact a poison control center immediately.

Do not use

if you have know sensitivities to any one of the ingredients.

When using this product

avoid contacts with eyes. If contact occurs, rinse eyes thoroughly with water.

• This product should be used only for the purpose it was intended and according to its instructions. 
  
• Do not ingest.
  

Directions

• Adults and children under 12 years of age and older
  
  Use twice daily after brushing your teeth with toothpaste
  Vigorously swish 10 ml of rinse between teeth for 1 minute and then spit out
  Do not swallow the rinse
  Do not eat or drink for 30 minutes after rinsing
  Supervise children as necessary until capable of using without supervision

• Children under 12 years of age: consult a dentist or doctor.
  

Inactive Ingredients:

Water, Sorbitol, Alcohol, Polysorbate 80, Poloxamer 338, Flavour, Sodium Saccharin, Bisabolol, Hydrogen Peroxide, Sodium Diethylenetriamine Pentamethylene Phosphonate, Phosphoric Acid, Limonene

Other information

Questions? Call (845) 501-0127

Principal Display Panel

NDC: 69939-129-06

ORBITOL

WHITENING

Teeth Whitening Mouthwash - Oral rinse

For Whitening the teeth

For the prevention of dental cavities

Keeps you breath fresh for many hours

Contains Fluoride to strengthen teeth

USA78113 R-01

nt wt 16.9 fl oz (500 gr)

ORBITOL WHITENING 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69939-129
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
ALCOHOL (UNII: 3K9958V90M)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
LEVOMENOL (UNII: 24WE03BX2T)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
POLOXAMER 338 (UNII: F75JV2T505)
PHOSPHORIC ACID (UNII: E4GA8884NN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69939-129-06	500 g in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2016	11/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/13/2016	11/30/2018

Labeler - COSMOPHARM LTD (600395487)

Revised: 8/2019

Document Id: 90b47c91-2a5a-833c-e053-2a95a90acb20

34390-5

Set id: 77239369-626c-496e-b7a9-02d465f1719e

Version: 4

Effective Time: 20190822