Spatherapy Anti-bacterial Hand Gel, Lemon Citrus

Spatherapy Antibacterial Lemon Citrus by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPATHERAPY ANTIBACTERIAL LEMON CITRUS- alcohol gel 
Shalom International Corp

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Spatherapy Anti-bacterial Hand Gel, Lemon Citrus

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, FD&C Yellow No.5, FD&C Red No.4. 

Package Labeling:

Label11

SPATHERAPY ANTIBACTERIAL LEMON CITRUS 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-170
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)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-170-0030 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: 1f07a563-ee2b-34f3-e063-6394a90a1163
Set id: b9bd9ed3-909a-212c-e053-2995a90a0af0
Version: 3
Effective Time: 20240806