ANTIBACTERIAL HAND- triclosan soap 
Hydrox Laboratories

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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Antibacterial Hand Soap

Drug Facts

Active ingredient

Triclosan 0.15%

Purpose

Antibacterial

Uses

For handwashing 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 thoroughly with water.

Keep out of reach of children.

  • If accidently ingested, seek medical help or contact a Poison Control Center immediately.
  • For children under 6, use only under adult supervision.

Directions

  • Wet hands.
  • Apply palmful to hands.
  • Scrub thoroughly.
  • Rinse.

Inactive ingredients

PURIFIED WATER, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, LAURAMIDE DEA, COCAMIDE DEA, COCAMIDOPROPYL BETAINE, AMMONIUM LAURYL SULFATE, AMMONIUM LAURETH SULFATE, SODIUM CUMENESULFONATE, SODIUM CHLORIDE, PROPYLENE GLYCOL, ALOE VERA, DMDM HYDANTOIN, FRAGRANCE, TOCOPHERYL ACETATE, FD&C YELLOW #5, D&C RED #4

MFG BY: HYDROX LABORATORIES
825-B Tollgate Road ELGIN, IL 60123

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

NDC 10565-073-02

Hydrox
Laboratories

ANTIBACTERIAL*
HAND SOAP

with moisturizers
& vitamin E

MADE IN
USA

2 FL OZ 59 mL

Principal Display Panel - 59 mL Bottle Label
ANTIBACTERIAL HAND 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10565-073
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan0.15 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sodium Laureth Sulfate (UNII: BPV390UAP0)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Lauric Diethanolamide (UNII: I29I2VHG38)  
Coco Diethanolamide (UNII: 92005F972D)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)  
Ammonium Laureth-2 Sulfate (UNII: 698O4Z48G6)  
Sodium Cumenesulfonate (UNII: 5798KA13PG)  
Sodium Chloride (UNII: 451W47IQ8X)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
DMDM Hydantoin (UNII: BYR0546TOW)  
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
FD&C Yellow No. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10565-073-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/19/201101/18/2014
2NDC:10565-073-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/19/201101/18/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E12/19/201101/18/2014
Labeler - Hydrox Laboratories (025164302)

Revised: 10/2017
Document Id: d09c31ad-d6c8-47b8-9a56-65d00aa28d28
Set id: cc96b0a2-4824-462d-9605-0e642f500504
Version: 2
Effective Time: 20171003
 
Hydrox Laboratories