Spatherapy Anti-bacterial Hand Gel Cherry Blossom

Spatherapy Anti bacterial Hand Cherry Blossom by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPATHERAPY ANTI BACTERIAL HAND CHERRY BLOSSOM- 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 Cherry Blossom

Drug Facts

Active Ingredient

Alcohol Denat 60% w/w

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 fire or flame.

Keep out of reach of children.

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

Do not get into eye.

If contact occurs, rinse thoroughly with water.

Discontinue use

if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor.

Directions

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

Inactive Ingredients

Water(Aqua), PEG-40 Hydrogenated Caster Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance(Parfum), Sodium Hydroxide, Tocopheryl Acetate, Simmndsia Chinensis (jojoba) Seed Wax, D&C Red 33(CI 17200), FD&C Red 4(CI 14700)

Package Labeling:

SPATHERAPY ANTI BACTERIAL HAND CHERRY BLOSSOM 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73025-041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.6 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73025-041-30	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020	06/01/2020

Labeler - Shalom International Corp (001384825)

Revised: 4/2020

Document Id: a3be5bf7-3a62-2300-e053-2995a90a8a34

34390-5

Set id: f93571fd-6d0c-45b2-b341-31cbc3cdbc29

Version: 3

Effective Time: 20200420