OCEAN BREEZE- ethyl alcohol gel

Ocean Breeze by

Drug Labeling and Warnings

Ocean Breeze by is a Otc medication manufactured, distributed, or labeled by Shanghai Weierya Daily Chemicals Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients

carbomer 940, Peg-12 dimethicone, propylene glycol,

tocopheryl acetate, triethanolamine, water

ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol 65% v/v

PURPOSE

Purpose

Antimicrobial

WARNINGS

Warnings

For external use only

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center

right away

INDICATIONS & USAGE

Uses

hand sanitizer to help reduce bacteria on skin

DOSAGE & ADMINISTRATION

Directions - Put a dime sized

drop onto hands and rub together briskly

until dry.

DO NOT USE

Do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

OTHER SAFETY INFORMATION

Flammable. Keep away

from fire or flame

STORAGE AND HANDLING

Other Information.

Store below 110 F (43C)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OCEAN BREEZE  
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58194-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58194-009-01	29 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/01/2013

Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Weierya Daily Chemicals Factory		420359333	manufacture(58194-009)