Spatherapy Anti-bacterial Hand Gel, French Lavender

Spatherapy Antibacterial French Lavender by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPATHERAPY ANTIBACTERIAL FRENCH LAVENDER- alcohol gel 
Shalom International Corp

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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:

SPATHERAPY ANTIBACTERIAL FRENCH LAVENDER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73025-169
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73025-169-00	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/15/2021	07/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/15/2021	07/01/2024

Labeler - Shalom International Corp (001384825)

Revised: 8/2024

Document Id: 1f0786ee-f5fd-037e-e063-6294a90adf66

34390-5

Set id: b9bd79f6-da12-bcf2-e053-2995a90a0e4a

Version: 3

Effective Time: 20240806