HAND CLEANSE- triclosan gel

Hand Cleanse by

Drug Labeling and Warnings

Hand Cleanse by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc., Ningbo Pulisi Daily Chemical Products Co., Ltd.. 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 20°C to 25°C (68° to 77°F)

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 
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-1413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.15 mg  in 1 mL

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 YELLOW NO. 5 (UNII: I753WB2F1M)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-1413-1	444 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/11/2013

Labeler - Greenbrier International, Inc. (610322518)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Pulisi Daily Chemical Products Co., Ltd.		529047265	manufacture(33992-1413)