Morlii Antibacterial Hand Sanitizer by Sonchin Biomedical Cosmetics Corp. Sonchin 019-01

Drug Details [pdf]

MORLII ANTIBACTERIAL HAND SANITIZER- benzalkonium chloride spray
Sonchin Biomedical Cosmetics Corp.

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.

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Sonchin 019-01

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

Helps reduce bacteria on the skin
Recommended for repeated use

Warnings

For external use only.

Do not use

on children less than 2 months of age
on open skin wounds
around eyes
in ears and mouth

When using this product

avoid contact with eyes. In case of eye contact, flush eyes with water

Stop use and ask a doctor

if irritation or rash occurs.

Keep out of reach of children.

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

Directions

Pump as need into your palms and thoroughly spread on both hands. Rub hands together briskly until dry.

Other information

Store between 20-25˚C (68-77˚F)

Inactive ingredients

Purified Water, Glycerine, Aloe Barbadensis Miller, Fragrance, Propylene Glycol, DMDM Hydantoin, Iodopropynyl Butylcarbamate, Polysorbate 20, Vitis Vinifera Fruit Extract, Hamamelis Extract

Package Label - Principal Display Panel

100 ml NDC: 73662-019-01 100ml_label

MORLII ANTIBACTERIAL HAND SANITIZER
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73662-019
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
GLYCERIN (UNII: PDC6A3C0OX)
2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL (UNII: 1ZRR9A405A)
WATER (UNII: 059QF0KO0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
ALOE (UNII: V5VD430YW9)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WINE GRAPE (UNII: 3GOV20705G)
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 73662-019-01	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/27/2020	12/31/2021

Labeler - Sonchin Biomedical Cosmetics Corp. (656155727)

Name	Address	ID/FEI	Business Operations
Establishment
Sonchin Biomedical Cosmetics Corp.		656155727	manufacture(73662-019)

Revised: 6/2022

Document Id: e14f5e54-dc6c-5756-e053-2a95a90a205b

Set id: b512f894-5e01-f3ba-e053-2995a90ae3ef

Version: 2

Effective Time: 20220613