HEALTH STAT - triclosan soap 
Triad Group

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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Health Stat 6215 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Triclosan 0.3%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin

Drug Facts Box OTC-Warnings Section

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

if swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box OTC-Dosage & Administration Section


wet hands and forearms

apply 5 milliliters (teaspoonful) or palmful to hands and forearms

scrub thoroughly for 1 minute and rinse

Drug Facts Box OTC-Inactive Ingredient Section

water, sodium laureth sulfate, sodium chloride, sodium lauryl sulfate, cocamidopropyl betaine, alcohol denat., propylene glycol, tetrasodium EDTA, PEG-75 lanolin,  boric acid, lauramine oxide, chloroxylenol, methylparaben, propylparaben, fragrance, aloe barbadensis, acid red 1, reactive green 12

Health Stat 6215 1000 ml bag

6215M5P5122A.jpg  Health Stat 1000 ml bagimage of bag label

HEALTH STAT 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63551-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.003 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
BORIC ACID (UNII: R57ZHV85D4)  
ALCOHOL (UNII: 3K9958V90M)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63551-220-131 in 1 BOX
1800 mL in 1 BAG
2NDC:63551-220-17437 mL in 1 BOTTLE, PLASTIC
3NDC:63551-220-05540 mL in 1 BOTTLE, PLASTIC
4NDC:63551-220-111000 mL in 1 BOTTLE, PLASTIC
5NDC:63551-220-181000 mL in 1 BAG
6NDC:63551-220-143785 mL in 1 BOTTLE, PLASTIC
7NDC:63551-220-15946 mL in 1 BOTTLE, PLASTIC
8NDC:63551-220-121 in 1 BOX
81000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33312/18/2000
Labeler - Triad Group (050259597)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture

Revised: 3/2010
Document Id: 3f1a3be7-28d3-40aa-bbbd-771d979e3507
Set id: bb8963d4-8088-4c6f-b697-624de49c40f9
Version: 1
Effective Time: 20100323
 
Triad Group