RITE AID RENEWAL ANTIBACTERIAL- triclosan liquid

RITE AID RENEWAL by

Drug Labeling and Warnings

RITE AID RENEWAL by is a Otc medication manufactured, distributed, or labeled by RITE AID CORPORATION, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

TRICLOSAN 0.15%

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 THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR

IF IRRITATION OR REDNESS DEVELOPS AND LASTS MORE THAN 7 DAYS.

KEEP OUT OF REACH OF CHILDREN

IF INGESTED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

APPLY A SMALL AMOUNT ONTO WET HANDS. WORK INTO A RICH LATHER AND RINSE CLEAN.

INACTIVE INGREDIENTS

WATER (AQUA), SODIUM C14-16 OLEFIN SULFONATE, LAURAMIDE DEA, SODIUM CHLORIDE, COCAMIDOPROPYL BETAINE, FRAGRANCE (PARFUM), CITRIC ACID, DMDM HYDANTOIN, GLYCERIN, TETRASODIUM EDTA, POLYQUATERNIUM-7, HYDROLYZED SILK PROTEIN, ALOE BARBADENSIS LEAF JUICE, RED 40 (CI 16035), YELLOW 5 (CI 19140), RED 33 (CI 17200).

LABEL COPY

INGREDIENTS AND APPEARANCE

RITE AID RENEWAL  ANTIBACTERIAL
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-2160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	1.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE SODIUM (UNII: MP1J8420LU)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-2160-8	221 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	12/21/2012

Labeler - RITE AID CORPORATION (014578892)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(11822-2160)