FAMILY DOLLAR  ANTIBACTERIAL - triclosan soap 
Family Dollar Services Inc.

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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Drug Facts

Active Ingredient

Triclosan 0.15%

Purpose

Antibacterial

Uses

• for hand washing to decrease bacteria on the skin.

Warnings

For external use only

When using this product

 • do not get into eyes • if contact occurs, rinse eyes with water.

Stop use and ask a doctor if

irritation or redness develops.

Keep out of the reach of children

If swallowed get medical help or contact a Poison Control Center right away.

Directions

•wet hands • apply palmful to hands • scrub thoroughly • rinse

Inactive ingredients

water, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, cocamide DEA, glycerin, fragrance, methylchloroisothiazolinone,  methylisothiazolinone,tetrasodium EDTA,  citric acid, benzophenone-4, FDC yellow no. 6, FDC yellow no. 5, DC red no. 33

Package Label

image of package label

FAMILY DOLLAR   ANTIBACTERIAL
triclosan soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-156
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.15 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BENZOPHENONE (UNII: 701M4TTV9O)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55319-156-75 221 mL in 1 BOTTLE, PUMP
2 NDC:55319-156-09 266 mL in 1 BOTTLE, PUMP
3 NDC:55319-156-11 333 mL in 1 BOTTLE, PUMP
4 NDC:55319-156-13 400 mL in 1 BOTTLE, PUMP
5 NDC:55319-156-14 414 mL in 1 BOTTLE, PUMP
6 NDC:55319-156-40 1180 mL in 1 BOTTLE, PLASTIC
7 NDC:55319-156-64 1890 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/21/2012
Labeler - Family Dollar Services Inc. (024472631)

Revised: 6/2013
Document Id: 460f6eb5-e5e9-4829-bb6b-1cea31ceac54
Set id: 754e6ac8-08ad-4850-b3af-06e0f83f9c46
Version: 2
Effective Time: 20130626
 
Family Dollar Services Inc.