ANTIBACTERIAL AMBER HAND SOAP- triclosan liquid

ANTIBACTERIAL AMBER HAND SOAP by

Drug Labeling and Warnings

ANTIBACTERIAL AMBER HAND SOAP by is a Otc medication manufactured, distributed, or labeled by Ningbo United Group Import and Export Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

ANTIBACTERIAL AMBER HAND SOAP 
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29860-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	.04 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29860-002-27	800 mL in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2010

Labeler - Ningbo United Group Import and Export Co. Ltd. (544900137)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo United Group Import and Export Co. Ltd.		544900137	manufacture