SIMPLY RIGHT SPARKLING MIST- triclosan liquid 
SAM'S WEST 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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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 WITH WATER

STOP USING THE PRODUCT AND ASK A DOCTOR IF

IRRITATION AND REDNESS DEVELOP AND LAST.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

SQUEEZE ONTO WET HANDS OR BODY SPONGE. WORK INTO A LATHER. WASH SKIN, RINSE AND DRY THOROUGHLY.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS:

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

LABEL COPY

IMAGE OF THE LABEL

SIMPLY RIGHT  SPARKLING MIST
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-808
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:68196-808-24710 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/12/2013
Labeler - SAM'S WEST INC (051957769)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(68196-808)

Revised: 8/2013
Document Id: aea2d91d-9cf8-435a-b4b2-35b0389165aa
Set id: f1780a95-4070-41bb-aa14-3941222a2b86
Version: 1
Effective Time: 20130812
 
SAM'S WEST INC