Spatherapy Anti-bacterial Hand Gel Vanilla Coconut

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]

SPATHERAPY ANTI BACTERIAL HAND VANILLA COCONUT- 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 Vanilla Coconut

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, FD&C Yellow 5 (CI 19140), FD&C Red 4 (CI 14700), FD&C Blue 1 (CI 42090), D&C Red 33 (CI 17200)

Package Labeling:

Label3

SPATHERAPY ANTI BACTERIAL HAND VANILLA COCONUT 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-042
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.6 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-042-3030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/202006/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/202006/01/2020
Labeler - Shalom International Corp (001384825)

Revised: 4/2020
Document Id: a3be581e-bfad-0a61-e053-2995a90a9440
Set id: 48b67034-b89d-4b53-bde5-2344fa294405
Version: 3
Effective Time: 20200420