HAND SANITIZER OCEAN BREEZE- ethyl alcohol gel

Hand Sanitizer Ocean Breeze by

Drug Labeling and Warnings

Hand Sanitizer Ocean Breeze by is a Otc medication manufactured, distributed, or labeled by Yiwu Sloggi Cosmetics Co.,ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient(s): Ethyl Alcohol 68%

PURPOSE

Purpose: Antiseptic

DOSAGE & ADMINISTRATION

Place enough product on hands to cover all surfaces.

WARNINGS

For external use only.

INACTIVE INGREDIENT

Isopropyl Alcohol

Water

Triethanolamine

Fragrance

INDICATIONS & USAGE

Rub hands together until dry.

KEEP OUT OF REACH OF CHILDREN

Keep away from children.

PRINCIPAL DISPLAY PANEL

30mL Ocean Breeze NDC: 54225-005-01

100mL Ocean Breeze NDC: 54225-005-02

500mL Ocean Breeze NDC: 54225-005-03

INGREDIENTS AND APPEARANCE

HAND SANITIZER OCEAN BREEZE 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54225-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	68 mL  in 68 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54225-005-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020
2	NDC: 54225-005-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020
3	NDC: 54225-005-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/07/2020

Labeler - Yiwu Sloggi Cosmetics Co.,ltd (542278522)

Establishment
Name	Address	ID/FEI	Business Operations
Yiwu Sloggi Cosmetics Co.,ltd		542278522	manufacture(54225-005)