ANTIBACTERIAL AMBER HAND SOAP - triclosan liquid 
Ningbo United Group Import and Export Co. Ltd.

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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Warnings

For external use only

  • flammable, keep away from fire and flame
  • will produce serious gastric disturbances if taken internally

Ask a doctor before use if you have deep puncture wounds or serious burns

When using this product

  • do not get into eyes or mucous membranes
  • use only in a well-ventilated area

Stop use and ask a doctor if condition persists or gets worse.

Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

Drug Facts

Active ingredients

Triclosan 0.04%

Purpose

Antibacterial

Uses

for hand washing to eliminate bacteria and germs on the skin.

Warnings

Warnings

For external use only.

Do not apply around eyes. Do not use in ears and mouth

When using this product, avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children. Children must be supervised in use of this product.

Directions

Wet hands. Apply palmful to hands. Scrub thoroughly. Rinse.

Other information

store at 20C (68F to 70F). May discolor fabrics.

Inactive ingredients

Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocamide DEA, Glycerin, Dipropylene Glycol, Sodium Chloride, Fragrance, PEG-250 Distearate, Methylchloroisothiazolinone, Methylisothiazolinone, Citric Acid, FD C Yellow No. 6

LabelEnter section text here

ANTIBACTERIAL AMBER HAND SOAP 
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29860-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN.04 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 77 mL  in 100 mL
SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 12 mL  in 100 mL
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 4 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) .70 mL  in 100 mL
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) .05 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .10 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29860-002-27800 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2010
Labeler - Ningbo United Group Import and Export Co. Ltd. (544900137)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo United Group Import and Export Co. Ltd.544900137manufacture

Revised: 3/2011
Document Id: b5cd8504-28fa-4a1a-8074-78fc20307fa6
Set id: 7831efe2-2339-427f-a7ae-c2078581f29c
Version: 1
Effective Time: 20110315
 
Ningbo United Group Import and Export Co. Ltd.