STUDIO 35 SPRING MORNING- triclosan liquid

STUDIO 35 by

Drug Labeling and Warnings

STUDIO 35 by is a Otc medication manufactured, distributed, or labeled by WALGREEN COMPANY, 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 THOROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION AND REDNESS DEVELOP AND LASTS.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

SQUEEZE A SMALL AMOUNT ONTO A WET WASHCLOTH, SPONGE, POUF OR HANDS AND APPLY TO BODY. WORK INTO A RICH LATHER AND RINSE OFF.

QUESTIONS OR COMMENTS?

1-800-925-4733

INACTIVE INGREDIENTS:

WATER (AQUA), SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-8, FRAGRANCE (PARFUM), GLYCERIN, ISPSTEARAMIDOPROPYL MORPHOLINE LACTATE, POLYQUATERNIUM-10, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE, DMDM HYDANTOIN, CITRIC ACID, TETRASODIUM EDTA, SODIUM CHLORIDE, BLUE 1 (CI 42090), RED 33 (CI 17200).

LABEL COPY

INGREDIENTS AND APPEARANCE

STUDIO 35  SPRING MORNING
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-3701
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 LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GLYCERIN (UNII: PDC6A3C0OX)
ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE (UNII: 082Y3WQI5K)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
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: 0363-3701-80	532 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	07/08/2013

Labeler - WALGREEN COMPANY (008965063)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(0363-3701)