HAND CLEANSE - OCEAN FRESH- triclosan gel

Hand Cleanse - Ocean Fresh by

Drug Labeling and Warnings

Hand Cleanse - Ocean Fresh by is a Otc medication manufactured, distributed, or labeled by China Ningbo Shangge Cosmetic Technology Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                   Purpose

Triclosan 0.15%..................................Antibacterial

PURPOSE

Uses

forthe temporary relief of minor aches and pains of muscles and joints.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

INDICATIONS & USAGE

Other information

• store at 20oC to 25oC (68o to 77oF)

WARNINGS

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with 

• smoking
• excessive phlegm
• asthma
• emphysema
• persistent or chronic cough

When using this product do not

• heat
• microwafe
• add to hot water or any container where healing water may cause splattering and result in burns
• use in eyes or directly on mucous membranes
• take by mouth or place in nostrils
• apply to wounds or damaged skin
• bandage skin

Consult a doctor and discontinue use if condition worsesn, persists for more than 1 week or tends to recur.

DOSAGE & ADMINISTRATION

Directions

• see important warnings under "When using this product"
• adults & children 2 years of age & older: apply to the affected area not more than 3 to 4 times daily.
• children under 2 years of age: consult a physician.

INACTIVE INGREDIENT

Inactive Ingredients

camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND CLEANSE - OCEAN FRESH 
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58503-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	7.5 mg  in 500 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58503-010-01	500 mg in 1 BOTTLE; Type 0: Not a Combination Product	05/24/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/24/2013

Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(58503-010)