P.O.V. Sugarfree: Package Insert and Label Information

P.O.V. SUGARFREE- eucalyptol, menthol, methyl salicylate and thymol mouthwash
Apollo Health and Beauty Care Inc.

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.

Active ingredients

Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Purpose

Antiplaque/Antigingivitis

Uses

helps reduce plaque that leads to

  • gingivitis
  • bleeding gums

Warnings

Stop use and ask a doctor if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodonitis, a serious form of gum disease.

Keep out of reach of children under 6 years of age.

If more than used for rinsing is accidently swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
  • children 6 years to under 12 years of age: supervise use
  • children under 6 years of age: do not use

Other information

  • this rinse is not intended to replace brushing or flossing
  • store at room temperature. Cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive ingredients

Water (Aqua), Alcohol (21.6%), Flavor, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sucralose, Sodium Benzoate, Green 3 (CI 42053).

Questions or comments?

1-866-695-3030

Label Copy

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P.O.V. SUGARFREE
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-565
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 0.92 mg in 1 mL
MENTHOL (MENTHOL) MENTHOL 0.42 mg in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.60 mg in 1 mL
THYMOL (THYMOL) THYMOL 0.64 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
POLOXAMER 407
BENZOIC ACID
SACCHARIN SODIUM
SUCRALOSE
SODIUM BENZOATE
FD&C GREEN NO. 3
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63148-565-33 1000 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 03/28/2018
Labeler — Apollo Health and Beauty Care Inc. (201901209)
Registrant — Apollo Health and Beauty Care Inc. (201901209)
Establishment
Name Address ID/FEI Operations
Apollo Health and Beauty Care Inc. 201901209 manufacture (63148-565)

Revised: 03/2018 Apollo Health and Beauty Care Inc.

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