Anti-bacterial Hand Gel Vanilla Sugar

Anti-bacterial Hand Gel Vanilla Sugar by

Drug Labeling and Warnings

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

Drug Details [pdf]

ANTI-BACTERIAL HAND GEL VANILLA SUGAR- 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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Anti-bacterial Hand Gel Vanilla Sugar

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.

If accidentally swallowed, get medical help or contact a Poison Control Center right away.

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 Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance(Parfum), Sodium Hydroxide, Tocopheryl Acetate, FD & C BLUE 1 (CI 42090), FD & C YELLOW 5 (CI 19140), D & C RED 33 (CI 17200).

Package Labeling:

Bottle3

ANTI-BACTERIAL HAND GEL VANILLA SUGAR 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-145
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-145-3030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/202012/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/202012/31/2020
Labeler - Shalom International Corp (001384825)

Revised: 3/2022
Document Id: d9298709-62da-0c57-e053-2995a90afb2a
Set id: af22add1-3594-4889-ad66-ff682deb427d
Version: 3
Effective Time: 20220301