Pomegranate & Vanilla Scented Hand Sanitizer Gel

Pomegranate and Vanilla Scented Hand Sanitizer by

Drug Labeling and Warnings

Pomegranate and Vanilla Scented Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Fourstar Group USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

POMEGRANATE AND VANILLA SCENTED HAND SANITIZER- alcohol gel 
Fourstar Group USA, Inc.

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Pomegranate & Vanilla Scented Hand Sanitizer Gel

Drug Facts

Active ingredient

Ethyl Alcohol, 70% v/v

Purpose

Antimicrobial

Uses

hand sanitizer to help reduce bacteria on skin

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation, excessive redness or rash develops.

Keep out of reach of children.

Supervise children under 6 years of age when using this product to avoid swallowing. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Put a dime sized drop onto hands and rub together briskly until dry.

Other information

Store below 110°F (43°C)

Inactive ingredients

water, carbomer, fragrance, triethanolamine, red 4

Package Labeling:

Outer Label3.jpgLabel3

POMEGRANATE AND VANILLA SCENTED HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80684-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80684-052-891 in 1 BOX12/01/202112/15/2023
189 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)12/01/202112/15/2023
Labeler - Fourstar Group USA, Inc. (140099503)

Revised: 12/2023
Document Id: 0d6c0bcb-23ce-5fb3-e063-6294a90a1ae6
Set id: 20941bd2-c9dc-41ff-b6df-d7251b19bc95
Version: 3
Effective Time: 20231226