ANTIBACTERIAL SPARKLING MIST- triclosan solution

ANTIBACTERIAL by

Drug Labeling and Warnings

ANTIBACTERIAL 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  0.15%

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 DOCTOR IF

IRRITATION AND REDNESS DEVELOP.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

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

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-8, FRAGRANCE, GLYCERIN, ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE, POLYQUATERNIUM-10, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE, DMDM HYDANTOIN, CITRIC ACID, PROPYLENE GLYCOL, NIACINAMIDE, HIBISCUS, SADARIFFA 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, SODIUM CHLORIDE, BLUE1, RED 33

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL  SPARKLING MIST
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68196-804
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.15 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-8 DIOLEATE (UNII: 6JR5A7273E)
GLYCERIN (UNII: PDC6A3C0OX)
INDELOXAZINE HYDROCHLORIDE (UNII: 15QZ6NE84E)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
NIACINAMIDE (UNII: 25X51I8RD4)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
EDETATE SODIUM (UNII: MP1J8420LU)
GINGER (UNII: C5529G5JPQ)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68196-804-24	720 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/17/2011

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