SIMPLY RIGHT BODY CARE 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

USE

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 THIS PRODUCT AND ASK A DOCTOR IF

IRRITATION AND REDNESS DEVELOPS AND LASTS.

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 (PARFUM), GLYCERIN, ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE, POLYQUATERNIUM-10, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE, DMDM HYDANTOIN, CITRIC ACID, PROPYLENE GLYCOL, NIACINAMIDE, HIBISCUS SABDARIFFA FLOWER EXTRACT, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, TETRASODIUM EDTA, BLUE 1 (CI 42090), RED 33 (CI 17200).

LABEL COPY

IMAGE OF TH ELABEL

SIMPLY RIGHT BODY CARE  SPARKLING MIST
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-809
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)  
ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE (UNII: 082Y3WQI5K)  
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NIACINAMIDE (UNII: 25X51I8RD4)  
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GINGER (UNII: C5529G5JPQ)  
CHAMOMILE (UNII: FGL3685T2X)  
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:68196-809-24710 mL in 1 BOTTLE, PLASTIC08/12/2013
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(68196-809)

Revised: 8/2013
Document Id: f1c33970-1c3f-4b87-b743-c943535a4ae0
Set id: aa308d91-43a4-4650-babb-1098fbc53d2b
Version: 1
Effective Time: 20130814
 
SAM'S WEST INC.