PUMPKIN SPICE SCENTED HAND SANITIZER- alcohol gel 
Fourstar Group USA, Inc.

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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PUMPKIN SPICE SCENTED HAND SANITIZER

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.

Flammble, 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, glycerin, propylene glycol, fragrance, carbomer, triethanolamine, yellow 6, red 4

Package Labeling:59ml

Outer Package6

IP66

Package Labeling:236ml

Outer Package07Inner Package07

PUMPKIN SPICE SCENTED HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-065
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80684-065-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2022
2NDC:80684-065-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/10/2022
Labeler - Fourstar Group USA, Inc. (140099503)

Revised: 5/2022
Document Id: dea4ecb6-4890-3646-e053-2995a90a54cc
Set id: f4de93d9-ac50-45af-aacd-62c7b325ce1c
Version: 1
Effective Time: 20220510
 
Fourstar Group USA, Inc.