CLINICAL WORKS OCEAN BREEZE WATERLESS HAND SANITIZER- alcohol liquid

Clinical Works Ocean Breeze Waterless Hand Sanitizer by

Drug Labeling and Warnings

Clinical Works Ocean Breeze Waterless Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Taizhou Xinzhixuan Daily-Use Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Ethyl Alcohol 62%

Purpose
Antisepic

DESCRIPTION

Uses

• To decrease bacteria on the skin that could cause disease.
• Recommended for repeated use

WARNINGS

Warnings

For external use only-hands. 
Flammable. Keep away from heat and flame.
When using this product, Keep out of eyes. In case of contact with eyes, flush thoroughly with water.  Avoid contact with broken skin. Do not inhale or ingest.
Stop use and ask a doctor if skin irritation develops.
Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

INDICATIONS & USAGE

Directions

Wet hands thoroughly with product and allow to dry without wiping.
For children under 6,use only under adult supervision.
Not recommended for infants.

WARNINGS AND PRECAUTIONS

Other Information

Do not store above 105F
May discolor some fabrics.
Harmful to wood finishes and plastics

INACTIVE INGREDIENT

Inactive Ingredients

water(Aqua), Glycerin, Triethanolamine, Carbomer, Fragrance(parfum), PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin, FD and C Yellow No. 5, FD and C Blue No. 1, FD and C Red No. 40

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

CLINICAL WORKS OCEAN BREEZE WATERLESS HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50593-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62.000 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	35.39999 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	1.0 g  in 100 g
TROLAMINE (UNII: 9O3K93S3TK)	0.25 g  in 100 g
CARBOMER 934 (UNII: Z135WT9208)	0.25 g  in 100 g
DMDM HYDANTOIN (UNII: BYR0546TOW)	0.4 g  in 100 g
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)	0.5 g  in 100 g
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.000002 g  in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.000006 g  in 100 g
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.000002 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50593-008-01	60 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	06/10/2010

Labeler - Taizhou Xinzhixuan Daily-Use Co., Ltd. (420438920)

Registrant - Taizhou Xinzhixuan Daily-Use Co., Ltd. (420438920)

Establishment
Name	Address	ID/FEI	Business Operations
Taizhou Xinzhixuan Daily-Use Co., Ltd.		420438920	manufacture