SPATHERAPY- benzalkonium chloride lotion

Spatherapy by

Drug Labeling and Warnings

Spatherapy by is a Otc medication manufactured, distributed, or labeled by Xiamen Olivee Daily Use Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients - Water, Sodium Laureth

Sulfate, Cocamidopropyl Betaine, Glycerin, DMDM

Hydantoin, Benalkonium Clhoride, Fragrance,

Xanthan Gum, Disodium EDTA,

Citiric Acid. May contain: CI 14700, CI 17200, CI 19140, Ci 42090

ACTIVE INGREDIENT

Active Ingredient

Benzalkonium Chloride  0,2 %

PURPOSE

Purpose

Antibacterial

INDICATIONS & USAGE

Use - handwashing to decrease bacteria on skin

DOSAGE & ADMINISTRATION

Directions - wet hands, work into

rich lather - rinse well

WARNINGS

Warnings

For external use only

WHEN USING

When using this product, avoid contact with eyes. If contact occurs,

rinse thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation and redness develop

KEEP OUT OF REACH OF CHILDREN

EKeep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.

QUESTIONS

Questions? 1-800-FDA-1088

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPATHERAPY  
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56136-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	.56 g  in 293 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56136-008-01	293 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/27/2014

Labeler - Xiamen Olivee Daily Use Chemical Co., Ltd. (526021375)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Olivee Daily Use Chemical Co., Ltd.		526021375	manufacture(56136-008)