SPATHERAPY ANTIBACTERIAL FRENCH LAVENDER- 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 Anti-bacterial Hand Gel, French Lavender

Drug Facts

Active ingredient

Alcohol Denat. 62%

Purpose

Antibacterial

Use

To decrease bacteria on the skin and clean hands. Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from flames.

When using this product

do not get into eye. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

irritation or redness develop or persists for more than 72 hours

Keep out of reach of children.

Directions

Apply to hands until thoroughly wet. Rub vigorously until dry.

Inactive ingredients

Water, Fragrance (Parfum), Carbomer, Aminomethyl Propanol, D&C Red No.33, FD&C Blue No.1.

Package Labeling:

Label10

SPATHERAPY ANTIBACTERIAL FRENCH LAVENDER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73025-169
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73025-169-0030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/15/2021
Labeler - Shalom International Corp (001384825)

Revised: 1/2021
Document Id: b9bd7fb0-2693-890b-e053-2995a90a8fc6
Set id: b9bd79f6-da12-bcf2-e053-2995a90a0e4a
Version: 1
Effective Time: 20210125
 
Shalom International Corp