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NDC 45942-1632-01 Mixed Sanitizing Towlettes Details

Mixed Sanitizing Towlettes

Mixed Sanitizing Towlettes is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by GIOVANNI COSMETICS INC. The primary component is .

Product Information

NDC	45942-1632
Product ID	45942-1632_6ef8bf6c-c623-4c41-b1b4-7b39b379d8b8
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Mixed Sanitizing Towlettes
Proprietary Name Suffix	Grapefruit Splash, Lavender Calm, Peppermint Surge
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	GIOVANNI COSMETICS INC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 45942-1632-01 (45942163201)

Pricing Information	N/A
NDC Package Code	45942-1632-1
Billing NDC	45942163201
Package	1 KIT in 1 BAG (45942-1632-1)
Marketing Start Date	2014-01-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e7739576-3eff-4291-b3a4-94cc7e0d55b7 Details

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

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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

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

Ingredient Name	Strength
Inactive Ingredients
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

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

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

Labeler - GIOVANNI COSMETICS INC (133710194)

Registrant - GIOVANNI COSMETICS INC (133710194)

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

Revised: 12/2017

Document Id: 6ef8bf6c-c623-4c41-b1b4-7b39b379d8b8

Set id: e7739576-3eff-4291-b3a4-94cc7e0d55b7

Version: 1

Effective Time: 20171220