SPATHERAPY VANILLA COCONUT- hand sanitizer gel

Spatherapy Anti bacterial Hand Vanilla Coconut by

Drug Labeling and Warnings

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

Drug Details [pdf]

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children

ACTIVE INGREDIENT

Alcohol Denatured 60% w/w

INDICATIONS & USAGE

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

PURPOSE

Purpose: Antibacterial

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

WARNINGS

Spatheraphy Vanilla Coconut

INGREDIENTS AND APPEARANCE

SPATHERAPY VANILLA COCONUT 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73025-030
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73025-030-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/31/2019

Labeler - Shalom International Corp (103291209)

Registrant - Regulatory Matters Consulting (080711165)