CAREONE ANTIBACTERIAL- triclosan liquid 
AMERICAN SALES COMPANY

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 0.15%

PURPOSE

ANTIBACTERIAL

USES

FOR WASHING TO DECREASE BACTERIA ON THE SKIN

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION AND REDNESS DEVELOPS

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

DIRECTIONS

SQUEEZE A SMALL AMOUNT ONTO A WET WASHCLOTH, SPONGE POUF OR HANDS AND APPLY TO BODY. WORK INTO A RICH LATHER AND RINSE OFF

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, SODIUM CHLORIDE, COCAMIDOPROPYL BETAINE, PEG-8, FRAGRANCE, GLYCERIN, POLYQUATERNIUM-10, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE, ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE, DMD HYDANTOIN, CITRIC ACID, TETRASODIUM EDTA, BLUE 1 (CI 42090), RED 33 (CI 17200)

LABEL COPY

IMAGE OF LABEL

CAREONE  ANTIBACTERIAL
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-807
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075)  
ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE (UNII: 082Y3WQI5K)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-807-18532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/23/2014
Labeler - AMERICAN SALES COMPANY (809183973)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(41520-807)

Revised: 3/2014
Document Id: b5e2fd0a-a463-42eb-ba5a-2b8e94426f7f
Set id: f4fca920-7910-457f-8072-227de08ee5a9
Version: 1
Effective Time: 20140324
 
AMERICAN SALES COMPANY