SIMPLY RIGHT BODY CARE ANTIBACTERIAL- triclosan liquid

SIMPLY RIGHT BODY CARE by

Drug Labeling and Warnings

SIMPLY RIGHT BODY CARE by is a Otc medication manufactured, distributed, or labeled by SAM'S WEST INC., APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SIMPLY RIGHT BODY CARE  ANTIBACTERIAL
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68196-145
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	1.15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68196-145-80	2360 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/25/2012

Labeler - SAM'S WEST INC. (051957769)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(68196-145)