Spatherapy Antibacterial Hand Gel, Watermelon

Spatherapy Antibacterial Watermelon by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPATHERAPY ANTIBACTERIAL WATERMELON- alcohol gel 
Shalom International Corp

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Spatherapy Antibacterial Hand Gel, Watermelon

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 Red No.4.

Package Labeling:

Label6

SPATHERAPY ANTIBACTERIAL WATERMELON 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-165
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 RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-165-0030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/202107/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)01/15/202107/01/2024
Labeler - Shalom International Corp (001384825)

Revised: 8/2024
Document Id: 1f076e5c-1f7f-9fbb-e063-6394a90a8886
Set id: b9bc5982-642b-1dc0-e053-2a95a90a6533
Version: 3
Effective Time: 20240806