SHORT TERM ORAL CARE SYSTEM- hydrogen peroxide kit

Short Term Oral Care System by

Drug Labeling and Warnings

Short Term Oral Care System by is a Otc medication manufactured, distributed, or labeled by Sage Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Use

Aids in the removal of secretions associated with sore mouth

INDICATIONS & USAGE

Warnings

Do not use:

• For more than 7 days unless told to do so by a doctor.
• Avoid Swallowing.

Stop use and ask a doctor if:

• Sore mouth symptoms do not improve in 7 days.
• Swelling, rash or fever develops.
• Irritation, pain or redness persists or worsens.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

• Use up to 4 times daily or as directed by a dentist or doctor.
• Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp. Instruct to expectorate.
• Children under 12 yeras of age: supervise use.
• Children under 3 years of age: consult a dentist or doctor.

Inactive Ingredients

Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI42090), Yellow 6 (CI15985)

Questions

Call toll free 800-323-2220

SPL UNCLASSIFIED SECTION

MADE IN U.S.A.

NOT MADE WITH NATURAL RUBBER LATEX

Short Term Oral Care System with Perox-A-Mint Solution

INGREDIENTS AND APPEARANCE

SHORT TERM ORAL CARE SYSTEM 
hydrogen peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-024

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-024-30	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	10/19/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	9 g
Part 2	1 BOTTLE, PLASTIC	44 mL
Part 3	1 TUBE	14 g

Part 1 of 3

SODIUM BICARBONATE 
other oral hygiene products

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	SODIUM BICARBONATE (UNII: 8MDF5V39QO)
INGR	CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
INGR	SODIUM LAURYL SULFATE (UNII: 368GB5141J)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	WATER (UNII: 059QF0KO0R)
INGR	SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 KIT
1		9 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
Cosmetic

Part 2 of 3

PEROX-A-MINT SOLUTION 
hydrogen peroxide mouthwash

Product Information
Item Code (Source)	NDC: 53462-075
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHOSPHORIC ACID (UNII: E4GA8884NN)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 KIT
1	NDC: 53462-075-30	44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/21/1998

Part 3 of 3

MOUTH MOISTURIZER 
other oral hygiene products

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	XYLITOL (UNII: VCQ006KQ1E)
INGR	CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	WATER (UNII: 059QF0KO0R)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	POLYSORBATE 80 (UNII: 6OZP39ZG8H)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
INGR	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
INGR	SPEARMINT OIL (UNII: C3M81465G5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 KIT
1		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
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/19/2016

Labeler - Sage Products LLC (054326178)

Registrant - Sage Products LLC (054326178)

Establishment
Name	Address	ID/FEI	Business Operations
Sage Products LLC		054326178	manufacture(53462-024, 53462-075)