ANTIBACTERIAL FOAMING- triclosan solution

ANTIBACTERIAL by

Drug Labeling and Warnings

ANTIBACTERIAL by is a Otc medication manufactured, distributed, or labeled by HYVEE INC, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

TRICLOSAN 0.46%

PURPOSE

ANTIBACTERIAL

USES

FOR HAND 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

IF IRRITATION AND REDNESS DEVELOP

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

APPLY ONTO DRY HANDS, WORK INTO LATHER. RINSE THOROUGHLY.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER (AQUA), SODIUM XYLENE SULFONATE, DIPROPYLENE GLYCOL, GLYCERIN, SODIUM PCA, AMMONIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, POLYQUATERNIUM-10, FRAGRANCE (PARFUM), DISODIUM PHOSPHATE, CETYL ALCOHOL, ALOE BARBADENSIS LEAF JUICE, CITRIC ACID, METHYLPARABEN, PROPYLPARABEN, RED 4 (CI 14700), YELLOW 5  (CI 19140)

LABEL COPY

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INGREDIENTS AND APPEARANCE

ANTIBACTERIAL  FOAMING
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42507-177
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.46 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42507-177-08	222 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/08/2011

Labeler - HYVEE INC (006925671)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture