LUCKY ANTIBACTERIAL HAND SOAP SUPERSOFT- triclosan liquid 
Delta Brands 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 0.1%

Purpose

Antibacterial

Uses

For handwashing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

For external use only

When using this product

avoid contact with eyes. In case of eye contact immediately flush eyes with water, call a doctor. Avoid contact with broken skin.
Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Keep out of reach of children

Children can only use this product with adult supervision. Do not drink. Not edible. In case of accidental ingestion seek professional assistance or contact Poison Control Center immediately.

Directions

Wet hands. Apply palmful to hands. Scrub thoroughly. Rinse. Recommended for repeated use

Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Cocamide DEA, Polyquaternium-7, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Benzophenone-4, Citric Acid, Alphatocopherol Acetate (Vitamin E), DC Yellow No. 10, FDC Blue No. 1

Package Label
image of package label

LUCKY ANTIBACTERIAL HAND SOAP  SUPERSOFT
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 900 KD) (UNII: B70CUU14M9)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
EDETATE SODIUM (UNII: MP1J8420LU)  
BENZOPHENONE (UNII: 701M4TTV9O)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20276-160-75222 mL in 1 BOTTLE, SPRAY
2NDC:20276-160-08237 mL in 1 BOTTLE, PUMP
3NDC:20276-160-09266 mL in 1 BOTTLE, PUMP
4NDC:20276-160-10296 mL in 1 BOTTLE, PUMP
5NDC:20276-160-11333 mL in 1 BOTTLE, PUMP
6NDC:20276-160-12355 mL in 1 BOTTLE, PUMP
7NDC:20276-160-13400 mL in 1 BOTTLE, PUMP
8NDC:20276-160-14414 mL in 1 BOTTLE, PUMP
9NDC:20276-160-15444 mL in 1 BOTTLE, PUMP
10NDC:20276-160-16500 mL in 1 BOTTLE, PUMP
11NDC:20276-160-32946 mL in 1 BOTTLE, PLASTIC
12NDC:20276-160-401183 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33309/01/2010
Labeler - Delta Brands Inc (102672008)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Pulisi Daily Chemical Co. Ltd.529047265manufacture
Establishment
NameAddressID/FEIBusiness Operations
Delta Dis Ticaret A.S.643703853manufacture
Establishment
NameAddressID/FEIBusiness Operations
Primo Ambalaj ve Kimya Sanayi ve Ticaret A S 356694526manufacture
Establishment
NameAddressID/FEIBusiness Operations
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil566220234manufacture
Establishment
NameAddressID/FEIBusiness Operations
Marmara Temizlik Maddeleri Sanayi Ve Ticaret Ltd STI356082250manufacture

Revised: 8/2010
Document Id: f3773273-2ffc-473d-b274-883d225540f4
Set id: c1712b21-d349-4552-b754-dd8d314e49b2
Version: 1
Effective Time: 20100818
 
Delta Brands Inc