Spatherapy Sanitizing Hand Wipes Lemon

Spatherapy Sanitizing Hand Wipes Lemon by

Drug Labeling and Warnings

Spatherapy Sanitizing Hand Wipes Lemon by is a Otc medication manufactured, distributed, or labeled by Shalom International Corp, Shandong Liaocheng Chaoyue Daily Necessities Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPATHERAPY SANITIZING HAND WIPES LEMON- benzalkonium chloride cloth 
Shalom International 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.

----------

Spatherapy Sanitizing Hand Wipes Lemon

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Uses

For hand sanitizing to decrease bacteria on the skin. recommended for repeat use

Warnings

For external use only.

Do Not Use

• In the eyes.
• if you are allergic to any of the ingredients.

When using this product

if eye contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation and redness develop and persist for more than 72 hours.

Keep out of reach of children

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

Directions

• Storage. Store at room temperature.
• Dispensing. Remove seal band. Lift tab at front of lid. Pull up corner of center sheet and thread through dispenser slit in lid. Close lid to retain moisture.
• Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
• Disposal. Dispose of used wipes in trash receptacle after use. Do not flush.

Inactive Ingredients

Water, Propylene glycol, Lemon extract, Glycerol

Questions?

Call 212-391-6970

Package Labeling:

Package Labeling:

SPATHERAPY SANITIZING HAND WIPES LEMON 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73025-146
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LEMON (UNII: 24RS0A988O)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73025-146-50	50 in 1 PACKAGE	07/15/2020	07/01/2022
1		4 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 73025-146-20	20 in 1 PACKAGE	07/15/2020	06/01/2022
2		4.5 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/15/2020	07/01/2022

Labeler - Shalom International Corp (001384825)

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Liaocheng Chaoyue Daily Necessities Co., Ltd.		550196375	manufacture(73025-146)

Revised: 10/2022

Document Id: ea2fb555-1eae-92b2-e053-2a95a90aacbd

34390-5

Set id: 89421912-f7b6-4ffd-aa08-6a85028a85de

Version: 4

Effective Time: 20221004