FAMILY DOLLAR ANTIBACTERIAL HAND- 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.

----------

Drug Facts

Active Ingredient

Triclosan 0.15%

Purpose

Antibacterial

Uses

• for hand washing to decrease bacteria on the skin.

Warnings

• For external use only

hands only

When using this product

• avoid contact with the 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 thoroughly

Inactive ingredients

water, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, cocamide DEA, glycerin, fragrance, Cocamidopropylamine Oxide, Decyl Glucoside, Po;yquatemium-7, methylisothiazolinone, tetrasodium EDTA, citric acid, benzophenone-4, FDC yellow no. 5, DC red no. 33

Package Label

FAMILY DOLLAR ANTIBACTERIAL HAND
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55319-512
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.15 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description
Packaging
1	NDC:55319-512-01	221 mL in 1 BOTTLE, PUMP
2	NDC:55319-512-02	1180 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/02/2014

Labeler - Family Dollar Services Inc. (024472631)

Name	Address	ID/FEI	Business Operations
Establishment
Ningbo Pulisi Daily Chemical Products Co.,Ltd.		529047265	manufacture(55319-512)