ANTIBACTERIAL FOAM WITH MOISTURIZERS- triclosan soap 
Chester Packaging, LLC

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 0.3%

Purpose

Antimicrobial

Uses

  • Handwash to help reduce bacteria that potentially can cause disease.

Warnings

  • For external use only.

Ask a doctor before use if you have

  • Deep wounds, animal bites or serious burns.

When using this product

  • Avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if

  • irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Keep out of reach of children.

  • If swallowed, seek immediate medical attention or call a Poison Control Center right away.

Directions

  • Wet hands, apply foam, lather for 30 seconds and rinse hands thoroughly.

Inactive ingredients

Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Propylene Glycol, Lauramide DEA, Cocamide DEA, Cocamidopropyl Betaine, Glycerine, Polyquaternium-7, Sodium Chloride, Sodium Cumenesulfonate, Citric Acid, DMDM Hydantoin, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothazolinone, Aloe Barbadensis Leaf Juice, and Tocopherol Acetate.

Package Label Principal Display Panel

Foam Antibacterial Soap with Moisturizers

48212

Foam Antibacterial Soap with Moisturizers

No Fragrance Added

Product Dispenser Label

Foam Antibacterial Soap with Moisturizers

No Fragrance Added

Pacific Garden

1200 mL (40.8 fl. oz.)

ANTIBACTERIAL FOAM  WITH MOISTURIZERS
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12462-502
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
EDETATE SODIUM (UNII: MP1J8420LU)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12462-502-124 in 1 CASE
11200 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/200712/31/2016
Labeler - Chester Packaging, LLC (004237806)

Revised: 1/2016
Document Id: 2a3fbb79-f886-6be1-e054-00144ff8d46c
Set id: 102d634e-7d12-42d5-a16d-0f5385a778df
Version: 2
Effective Time: 20160126
 
Chester Packaging, LLC