HYDROGEN PEROXIDE liquid KIMVENT ORAL CARE SUCTION SWAB PACK- hydrogen peroxide kit

Kimvent Oral Care Suction Swab pack by

Drug Labeling and Warnings

Kimvent Oral Care Suction Swab pack by is a Otc medication manufactured, distributed, or labeled by Halyard Health, Avent, Elba Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Oral Debriding Agent

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Hydrogen Peroxide 1.5%

Purpose

Oral Debriding Agent

Uses

• Aids in the removal of phlegm, mucus, or other secretions in the temporary relief of discomfort due to occasional sore throat and sore mouth.

Warnings

Stop use and ask a doctor if:

• Swelling, rash, or fever develop.
• Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting occurs.
• Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.

Keep out of reach of children under 3 years of age.

Directions

• Topical dosage for adults and children 3 years of age and older is a rinse used no more than 4 times daily. For children under 3 years of age, there is no recommended dosage except under the advice and supervision of a dentist or doctor.
• Use only under health care practitioners supervision.

Other Information

• Store at room temperature.

Inactive Ingredients

Purified Water, Glycerin, Flavor, Sodium Saccharin

Questions or Comments?

1-800-KCHELPS

PRINCIPAL DISPLAY PANEL - 44 ml Bottle Label

Kimberly-Clark*

KimVent*
Hydrogen Peroxide
Oral Rinse,
Mint-Flavored

44 ml (1.5 fl. oz.)

Alcohol-Free

Single Use Only

REF 12263

20-64-001-0-02

LOT

Use By

PRINCIPAL DISPLAY PANEL - Kit Carton

Peel Here

Kimberly-Clark*

KimVent*
Suction Swab
Pack with H2O2

Contains:

• 1 Suction Swab
• 1 Applicator Swab
• 0.50 fl. oz. (14mL) of 1.5% H2O2 Oral Debriding Agent
• 0.07 oz. (2g) Mouth Moisturizer
  Purified Water, Propylene Glycol, Sorbitol, Hydroxypropyl Methylcellulose, Dimethicone, Flavor,
  Xylitol, Aloe Vera Gel, Potassium Sorbate, Sodium Benzoate, Potassium Chloride, Sodium Chloride

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55118-990
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V)	Hydrogen Peroxide	0.015 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Mint (UNII: FV98Z8GITP)
Saccharin Sodium (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55118-990-01	44 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	08/26/2008

KIMVENT ORAL CARE SUCTION SWAB PACK 
hydrogen peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55118-993

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55118-993-01	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CUP	14 mL
Part 2	1 TUBE	2 g

Part 1 of 2

HYDROGEN PEROXIDE 
hydrogen peroxide liquid

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V)	Hydrogen Peroxide	0.015 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Mint (UNII: FV98Z8GITP)
Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		14 mL in 1 CUP; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	08/26/2008

Part 2 of 2

MOUTH MOISTURIZER 
moisturizing salve

Product Information
Route of Administration	ORAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Aloe Vera Flower (UNII: 575DY8C1ER)
INGR	Water (UNII: 059QF0KO0R)
INGR	Xylitol (UNII: VCQ006KQ1E)
INGR	Propylene Glycol (UNII: 6DC9Q167V3)
INGR	Potassium Sorbate (UNII: 1VPU26JZZ4)
INGR	Sorbitol (UNII: 506T60A25R)
INGR	Hydroxypropyl Cellulose (Type H) (UNII: RFW2ET671P)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	Potassium Chloride (UNII: 660YQ98I10)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		08/26/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/26/2008

Labeler - Halyard Health (079617666)

Establishment
Name	Address	ID/FEI	Business Operations
Avent		049316284	MANUFACTURE(55118-990, 55118-993) , RELABEL(55118-993) , REPACK(55118-993)

Establishment
Name	Address	ID/FEI	Business Operations
Elba Laboratories		108428483	MANUFACTURE(55118-990, 55118-993)