MIXED SANITIZING TOWLETTES GRAPEFRUIT SPLASH, LAVENDER CALM, PEPPERMINT SURGE- benzalkonium chloride kit

Mixed Sanitizing Towlettes by

Drug Labeling and Warnings

Mixed Sanitizing Towlettes by is a Otc medication manufactured, distributed, or labeled by GIOVANNI COSMETICS INC, Diamond Wipes International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

   Benzalkonium Chloride 0.13%

Purpose

Antimicrobial 

Uses

For hand sanitizing to decrease bacteria on the skin

Directions

Open packet, unfold and rub thoroughly over hand

Warnings

For external use only.
When using this product avoid contact with eyes.
If irritation and redness develop and lasts, stop using this product and ask a doctor.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Inactive Ingredients

Grapefruit SplashTM: Aloe Barbadensis Leaf Juice, Citric Acid, Citrus Grandis (Grapefruit) Peel Oil, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate (Vitamin E Acetate), Water Lavender CalmTM: Aloe Barbadensis Leaf Juice, Citric Acid, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate (Vitamin E Acetate), Water Peppermint SurgeTM: Aloe Barbadensis Leaf Juice, Citric Acid, Mentha Piperita (Peppermint) Oil, Mentha Virdis (Spearmint) Leaf Oil, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate (Vitamin E Acetate), Water

Questions

1-800-563-5458 Monday thru Friday 8:00 AM - 5:00 PM PST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIXED SANITIZING TOWLETTES  GRAPEFRUIT SPLASH, LAVENDER CALM, PEPPERMINT SURGE
benzalkonium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45942-1632

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45942-1632-1	1 in 1 BAG; Type 0: Not a Combination Product	01/20/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1		7
Part 2		7
Part 3		6

Part 1 of 3

REFRESH SANITIZING TOWLETTE  ORGANIC GRAPEFRUIT SPLASH
benzalkonium chloride liquid

Product Information
Item Code (Source)	NDC: 45942-1629
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	.13

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
grapefruit (UNII: O82C39RR8C)
polysorbate 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/20/2010

Part 2 of 3

RECHARGE SANITIZING TOWLETTE  ORGANIC PEPPERMINT SURGE
benzalkonium chloride liquid

Product Information
Item Code (Source)	NDC: 45942-1630
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	.13

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SPEARMINT OIL (UNII: C3M81465G5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/20/2010

Part 3 of 3

RELAX SANITIZING TOWLETTE  ORGANIC LAVENDER CALM
benzalkonium chloride liquid

Product Information
Item Code (Source)	NDC: 45942-1631
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	.13

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
LAVENDER OIL (UNII: ZBP1YXW0H8)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/20/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/20/2014

Labeler - GIOVANNI COSMETICS INC (133710194)

Registrant - GIOVANNI COSMETICS INC (133710194)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes International		161104729	manufacture(45942-1632)