SIMPLY RIGHT BODY CARE ANTIBACTERIAL- 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.

----------

DRUG FACTS

ACTIVE INGREDIENT

TRICLOSAN 0.115%

PURPOSE

ANTIBACTERIAL

USES

FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

DO NOT GET INTO EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

IRRITATION OR REDNESS DEVELOPS AND LASTS.

DIRECTIONS

USE REFILL TO FILL PUMP BOTTLE. FROM PUMP BOTTLE, APPLY SOAP TO WET HANDS, RUB THOROUGHLY AND RINSE WELL.

INACTIVE INGREDIENTS

WATER (AQUA), SODIUM LAURETH SULFATE, LAURAMIDE DEA, COCAMIDOPROPYL BETAINE, DECYL GLUCOSIDE, POLYQUATERNIUM-7, SACCHAROMYCES, HYDROLYZED VEGEATBLE PROTEIN, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, NIACINAMIDE, TETRASODIUM EDTA, SODIUM CHLORIDE, FRAGRANCE (PARFUM), DMDM HYDANTOIN, CITRIC ACID, RED 33 (CI 17200), BLUE 1 (CI 42090).

LABEL COPY

IMAGE OF THE LABEL

SIMPLY RIGHT BODY CARE  ANTIBACTERIAL
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-145
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
SOY PROTEIN (UNII: R44IWB3RN5)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
NIACINAMIDE (UNII: 25X51I8RD4)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-145-802360 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/25/2012
Labeler - SAM'S WEST INC. (051957769)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(68196-145)

Revised: 10/2012
Document Id: 394ec837-7cc2-4dd6-a463-6ba1d565c8e0
Set id: 8007e373-70c0-4dfe-a0a8-59a3704b56ea
Version: 1
Effective Time: 20121025
 
SAM'S WEST INC.