OCEAN BREEZE SCENTED ANTIBACTERIAL HAND SANITIZER- alcohol gel

Ocean Breeze Scented Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Ocean Breeze Scented Antibacterial 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]

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, glycerin, propylene glycol, fragrance, carbomer, triethanolamine, blue 1

Package Labeling:

INGREDIENTS AND APPEARANCE

OCEAN BREEZE SCENTED ANTIBACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80684-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80684-005-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	11/07/2020

Labeler - Fourstar Group USA, Inc. (140099503)