DISNEY PRINCESS CHERRY SCENTED HAND SANITIZER 01- benzalkonium chloride gel DISNEY PRINCESS WATERMELON SCENTED HAND SANITIZER

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
ShenZhen Lantern Science Co.,Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Benzalkonium chloride 0.1% Antibacterial To decrease bacteria on the skin that could cause disease.
Authorization status:
OTC monograph not final
Authorization number:
54860-117-01, 54860-118-01

DISNEY PRINCESS CHERRY SCENTED HAND SANITIZER 01- benzalkonium chloride gel

DISNEY PRINCESS WATERMELON SCENTED HAND SANITIZER 01- benzalkonium

chloride gel

ShenZhen Lantern Science Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug facts

Active ingredient purpose

Benzalkonium chloride 0.1% Antibacterial

Us e

To decrease bacteria on the skin that could cause disease.

Warnings

For external use only-hands

keep out of eyes- avoid contact with broken skin

Stop use and ask a dosctor if irritation or radness develops

Do not inhale or ingest. If swallowed, get medical help or contact a poison control right away.

Direction

Rub a dime sized drop into hands.

For children under 6 use under adult supervision

Inactive ingredients

INACTIVE INGREDIENTS: WATER, GLYCERIN, COCETH-7, PPG-1-PEG-9 LAURYL GLYCOL

ETHER, CARBOMER, SODIUM HYDROXIDE, PEG-40 HYDROGENATED CASTOR OIL,

FRAGRANCE (PARFUM).

MAY CONTAIN: RED 40, RED 33, BLUE 1, YELLOW 5.

Ques tions ?

1-212-779-0544 weekdays

DISNEY PRINCESS CHERRY SCENTED HAND SANITIZER 01

benzalkonium chloride gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:548 6 0 -117

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .1 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PO LYO XYL 4 0 HYDRO GENATED CASTO R O IL (UNII: 7YC6 8 6 GQ8 F)

0 .15 mL in 10 0 mL

CO CETH-7 (UNII: 58 Y26 1JLH5)

0 .6 8 mL in 10 0 mL

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

0 .1 mL in 10 0 mL

MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71)

0 .3 mL in 10 0 mL

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

0 .1 mL in 10 0 mL

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

0 .1 mL in 10 0 mL

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

0 .1 mL in 10 0 mL

WATER O -18 (UNII: 7QV8 F8 BYNJ)

9 6 mL in 10 0 mL

CARBO MER 9 3 4 (UNII: Z135WT9 20 8 )

0 .24 mL in 10 0 mL

GLYCERIN (UNII: PDC6 A3C0 OX)

0 .6 8 mL in 10 0 mL

PPG-1-PEG-9 LAURYL GLYCO L ETHER (UNII: 5R8 J43K25L)

0 .6 8 mL in 10 0 mL

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

0 .12 mL in 10 0 mL

Product Characteristics

Color

re d

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:548 6 0 -117-

59 mL in 1 BOTTLE, PLASTIC; Type 1: Co nvenience Kit o f Co -

Pa c ka ge

0 7/31/20 19

0 7/31/20 22

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 7/31/20 19

0 7/31/20 22

DISNEY PRINCESS WATERMELON SCENTED HAND SANITIZER 01

benzalkonium chloride gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:548 6 0 -118

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .1 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER O -18 (UNII: 7QV8 F8 BYNJ)

9 6 mL in 10 0 mL

GLYCERIN (UNII: PDC6 A3C0 OX)

1.5 mL in 10 0 mL

CO CETH-7 (UNII: 58 Y26 1JLH5)

0 .6 8 mL in 10 0 mL

PPG-1-PEG-9 LAURYL GLYCO L ETHER (UNII: 5R8 J43K25L)

0 .6 8 mL in 10 0 mL

CARBO MER 9 3 4 (UNII: Z135WT9 20 8 )

0 .24 mL in 10 0 mL

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

0 .12 mL in 10 0 mL

PO LYO XYL 4 0 HYDRO GENATED CASTO R O IL (UNII: 7YC6 8 6 GQ8 F)

0 .15 mL in 10 0 mL

MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71)

0 .3 mL in 10 0 mL

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

0 .1 mL in 10 0 mL

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

0 .1 mL in 10 0 mL

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

0 .1 mL in 10 0 mL

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

0 .1 mL in 10 0 mL

Product Characteristics

ShenZhen Lantern Science Co.,Ltd.

Product Characteristics

Color

gre e n

S core

S hap e

S iz e

Flavor

WATERMELON

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:548 6 0 -118 -

59 mL in 1 BOTTLE, PLASTIC; Type 1: Co nvenience Kit o f Co -

Pa c ka ge

0 7/31/20 19

0 7/31/20 22

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 7/31/20 19

0 7/31/20 22

Labeler -

ShenZhen Lantern Science Co.,Ltd. (421222423)

Registrant -

T ownley Inc. (016956158)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ShenZhen Lantern Science Co .,Ltd.

421222423

manufacture(548 6 0 -117, 548 6 0 -118 )

Revised: 7/2019

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