HAND CLEANSE- triclosan gel 
China Ningbo Shangge Cosmetic Technology Corp.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hand Cleanse

Active Ingredient                                   Purpose

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

Uses

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

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

Other information

  • store at 20oC to 25oC (68o to 77oF)

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.

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 Ingredients

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

label image

HAND CLEANSE 
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN7.5 mg  in 500 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58503-009-01500 mg in 1 BOTTLE; Type 0: Not a Combination Product05/24/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/24/2013
Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-009)

Revised: 9/2019
 
China Ningbo Shangge Cosmetic Technology Corp.