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 Package07 Inner Package07

PUMPKIN SPICE SCENTED HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80684-065
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80684-065-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2022
2	NDC:80684-065-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	05/10/2022

Labeler - Fourstar Group USA, Inc. (140099503)