STUDIO 35 AMBER- benzalkonium chloride 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, APOLLO HALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE 0.13%

PURPOSE

ANTIBACTERIAL

USES

HELPS ELIMINATE BACTERIA ON HANDS.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IN CASE OF CONTACT, RINSE WITH WATER.

STOP USE AND ASK A DOCTOR IF

IRRITATION OR REDNESS DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

APPLY ONTO WET HANDS. LATHER AND RINSE THOROUGHLY.

OTHER INFORMATION

STORE AT ROOM TEMPARATURE.

INACTIVE INGREDIENTS:

WATER (AQUA), CETRIMONIUM CHLORIDE, GLYCERIN, LAURYL/MYRISTYL AMIDOPROPYL AMINE OXIDE, COCAMIDE MEA, SODIUM CHLORIDE, PEG-120 METHYL GLUCOSE DIOLEATE, FRAGRANCE (PARFUM), CITRIC ACID, TETRASODIUM EDTA, SODIUM SULFATE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 40 (CI 16035), YELLOW 5 (CI 19140), RED 33 (CI 17200). 

QUESTIONS OR COMMENTS?

1-800-925-4733

LABEL COPY

INGREDIENTS AND APPEARANCE

STUDIO 35  AMBER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-7215
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
GLYCERIN (UNII: PDC6A3C0OX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM SULFATE (UNII: 0YPR65R21J)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
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: 0363-7215-60	1650 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 HALTH AND BEAUTY CARE		201901209	manufacture(0363-7215)