Spatherapy Sanitizing Hand Wipes Aloe Vera

Spatherapy Sanitizing Hand Wipes Aloe Vera by

Drug Labeling and Warnings

Spatherapy Sanitizing Hand Wipes Aloe Vera 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 ALOE VERA- 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 Aloe Vera

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 barbadensis leaf extract, Glycerol, Cetylpyridinium chloride.

Questions?

  • Call 212-391-6970

Package Labeling

Label9

SPATHERAPY SANITIZING HAND WIPES ALOE VERA 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-072
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)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-072-00100 in 1 PACKET06/30/202012/31/2021
15 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 finalpart333E06/30/202012/31/2021
Labeler - Shalom International Corp (001384825)

Revised: 3/2022
Document Id: dad1294d-366e-3ced-e053-2a95a90a1468
Set id: e597b6d3-e9ce-4659-9d56-e235f0deaad6
Version: 3
Effective Time: 20220322