CVS Pharmacy, Inc. Dry Mouth Rinse Drug Facts

Dry Mouth by

Drug Labeling and Warnings

Dry Mouth by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRY MOUTH- sodium fluoride rinse 
CVS Pharmacy

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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CVS Pharmacy, Inc. Dry Mouth Rinse Drug Facts

Active ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in prevention of dental cavities.

Warnings

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

• use twice a day after brushing your teeth with a toothpaste
• vigorously swish 10 mL (2 spoonfuls) of rinse between your teeth for 1 minute and then spit out
• DO NOT SWALLOW THE RINSE
• do not eat or drink for 30 minutes after rinsing
• instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
• supervise children as necessary until capable of using without supervision

Children under 6 years of age: consult a dentist or doctor

Other information

• Store at room temperature 59°-77°F (15°-25°C)
• Do not use if printed seal on cap is removed
• Cold weather may temporarily cloud product, shake well if this occurs

Inactive Ingredients

purified water, propylene glycol, glycerin, PEG-40 hydrogenated castor oil, poloxamer 407, sodium benzoate, xylitol, flavor, cetylpyridinium chloride, sucralose, disodium EDTA, tetrasodium pyrophosphate, disodium phosphate, sodium phosphate, FD&C blue #1

Package/Label Principal Display Panel

Alcohol Free

CVS Health®

Compare to the active ingredient in ACT® Total Care Dry Mouth

Anticavity

Dry Mouth Rinse

SODIUM FLUORIDE 0.02%

SOOTHES DRY MOUTH

- Soothing relief

- Moisturizes mouth tissue

- Fights tartar & strengthens teeth

- Freshens breath

Mild Mint

IMPORTANT: Read directions for proper use.

18 FL OZ (532 mL)

GPE4417F1

DRY MOUTH 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-518
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XYLITOL (UNII: VCQ006KQ1E)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SUCRALOSE (UNII: 96K6UQ3ZD4)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-518-44	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2021	04/25/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/12/2021	04/25/2023

Labeler - CVS Pharmacy (062312574)

Revised: 12/2022

Document Id: 1b90b2a3-c3df-484f-8dc9-8593d2f4d3a0

34390-5

Set id: a9c5bc24-f587-4089-bf25-fbfb3bbbe970

Version: 2

Effective Time: 20221220

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