Spatherapy Sanitizing Hand Wipes

Spatherapy Sanitizing Hand Wipes by

Drug Labeling and Warnings

Spatherapy Sanitizing Hand Wipes by is a Otc medication manufactured, distributed, or labeled by Shalom International Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPATHERAPY SANITIZING HAND WIPES- 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

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 & 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, Aloe extract, Glycerol

Questions?

  • Call 212-391-6970

Package Labeling:20 wipes

Label7

Package Labeling:50 wipes

Label8

SPATHERAPY SANITIZING HAND WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-069
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-069-0020 in 1 PACKET06/15/202008/01/2022
15 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC: 73025-069-0150 in 1 PACKET06/15/202008/01/2022
25 mL 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 finalpart333E06/15/202008/01/2022
Labeler - Shalom International Corp (001384825)

Revised: 10/2022
Document Id: ea2fb555-1eac-92b2-e053-2a95a90aacbd
Set id: 07f3457a-ac0e-4552-b467-1b42a89d40af
Version: 3
Effective Time: 20221004