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NDC 45942-1631-02 Relax Sanitizing Towlette 0.13 g/100mL Details

Relax Sanitizing Towlette 0.13 g/100mL

Relax Sanitizing Towlette is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by GIOVANNI COSMETICS INC. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	45942-1631
Product ID	45942-1631_b61dc84c-f940-4ea5-871f-7228bb889e25
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	Relax Sanitizing Towlette
Proprietary Name Suffix	Organic Lavender Calm
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.13
Active Ingredient Units	g/100mL
Substance Name	BENZALKONIUM CHLORIDE
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 45942-1631-02 (45942163102)

Pricing Information	N/A
NDC Package Code	45942-1631-2
Billing NDC	45942163102
Package	24 PACKET in 1 CARTON (45942-1631-2) / 3 mL in 1 PACKET (45942-1631-1)
Marketing Start Date	2010-01-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 70914fc3-1ada-450d-a4eb-7db283030d5f Details

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Keep out of reach of children

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

Uses

For hand sanitizing to decrease bacteria on skin.

Directions

Open packet, unfold and rub thoroughly over hands.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Citric Acid, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate (Vitamin E Acetate), Water

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 doct

Questions

1-800-563-5468 Monday thru Friday 8:00AM - 5:00PM PST

PRINCIPAL DISPLAY PANEL

Relax Sanitizing Towelette

Lavender Calm

Made with organic lavender essential oil.

INGREDIENTS AND APPEARANCE

RELAX SANITIZING TOWLETTE ORGANIC LAVENDER CALM

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	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	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
LAVENDER OIL (UNII: ZBP1YXW0H8)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALOE (UNII: V5VD430YW9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:45942-1631-2	24 in 1 CARTON	01/20/2010
1	NDC:45942-1631-1	3 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC:45942-1631-3	60 mL in 1 PACKAGE; Type 0: Not a Combination Product	01/20/2014

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

Labeler - GIOVANNI COSMETICS INC (133710194)

Registrant - GIOVANNI COSMETICS INC (133710194)

Name	Address	ID/FEI	Business Operations
Establishment
Diamond Wipes International		161104729	manufacture(45942-1631)

Revised: 1/2018

Document Id: b61dc84c-f940-4ea5-871f-7228bb889e25

Set id: 70914fc3-1ada-450d-a4eb-7db283030d5f

Version: 10

Effective Time: 20180129