Drug Labeling and Warnings

Drug Details

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T-CHEM E2 RATED- chloroxylenol, triclosan soap 
AMERICAN CHEMICAL AND SANITARY SUPPLY 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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ACTIVE INGREDIENT:

Chloroxylenol 0.45%

Triclosan 0.06%

PURPOSE:

Antiseptic

FIRST AID:

EYES: AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER. CALL PHYSICIAN IF IRRITATION OR REDNESS DEVELOPS AND LASTS.

INGESTION: IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL OR CONTACT A POISON CNTROL CENTER IMMEDIATELY.

CONTAINER DISPOSAL: RINSE THREE TIMES WITH WATER. THEN OFFER FOR RECYCLING OR RECONDITIONING OR PUNCTURE AND DISPOSE OF IN A SANITARY LANDFILL OR BY INCARCERATION OR, IF ALLOWED BY STATE AND LOCAL AAUTHORITIES, BY BURNING. IF BURNED, STAY AWAY FROM SMOKE.

USES: Hygienic disinfectant.

FOR USE BY SERVICE PROFESSIONALS ONLY.

KEEP OUT OF REACH OF CHILDREN.

INACTIVE INGREDIENTS: WATER

DIRECTIONS:

POUR GEL INTO DISPENSER AND USE STRAIIGHT; DO NOT DILUTE. WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING. FOR EXTERNAL USE ONLY.

Label1095-E2Soap032814

T-CHEM E2 RATED 
chloroxylenol, triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50536-192
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.45 g  in 100 mL
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.06   in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50536-192-12800 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/12/2014
Labeler - AMERICAN CHEMICAL AND SANITARY SUPPLY INC (177148699)

Revised: 9/2014
 
AMERICAN CHEMICAL AND SANITARY SUPPLY INC


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