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.

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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:

Label

Package Labeling:

Label20ct

SPATHERAPY SANITIZING HAND WIPES LEMON 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-146
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LEMON (UNII: 24RS0A988O)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-146-5050 in 1 PACKAGE07/15/202007/01/2022
14 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC: 73025-146-2020 in 1 PACKAGE07/15/202006/01/2022
24.5 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/15/202007/01/2022
Labeler - Shalom International Corp (001384825)
Establishment
NameAddressID/FEIBusiness Operations
Shandong Liaocheng Chaoyue Daily Necessities Co., Ltd.550196375manufacture(73025-146)

Revised: 10/2022