Spatherapy Hand sanitizer

Spatherapy Hand sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPATHERAPY HAND SANITIZER- alcohol gel 
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 Hand sanitizer

Drug Facts

Active ingredient

Alcohol Denat. 70%

Purpose

Antibacterial 

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease  Recommended for repeated use.

Warnings

  • For external use only. 
  • Flammable, keep away from fire or flame.

When usingthis product 

do not use in or near the eyes. In cawsaey o ff rcoomnt aficrte, roinrs fela emyees. thoroughly with water.

Stop use and ask a doctor if

irritation or rash appears and lasts.

Keep out of reach of children.

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

Directions

Apply enough product to thoroughly cover hands. Rub hands together briskly until dry.

Other information

Do not store above 110˚F (43˚C). May discolor certain fabrics or surfaces

Inactive ingredients:

Water (Aqua), Carbomer, Fragrance (Parfum), Aminomethyl Propanol, Aloe Barbadensis Leaf Extract.

Questions?

Call 212-391-6970

Package Labeling:

Bottle2

SPATHERAPY HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-500-00500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/202012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/202012/31/2021
Labeler - Shalom International Corp (001384825)

Revised: 4/2022
Document Id: dcf30773-97f2-0795-e053-2995a90afa04
Set id: dedb1dc8-6232-4d19-a513-a4a8b5327246
Version: 3
Effective Time: 20220418