SPATHERAPY- alcohol lotion

Spatherapy by

Drug Labeling and Warnings

Spatherapy by is a Otc medication manufactured, distributed, or labeled by TRIZ LABORATORIES LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients

Water, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30

Alkyl Acrylate Crosspolymer, DMDM Hydantoin, Parfum,

Sodium Hydroxide, Tocopherol Acetate,

Simmondsia, Chinensis

(Jojoba) Seed Wax,

CI 19140, CI 14700

ACTIVE INGREDIENT

Active Ingredient

Alcohol Denat 60 % w/w

PURPOSE

Purpose Antibacterial

INDICATIONS & USAGE

Use - To decrease bacteria

on the skin and clean hands - Recommended

for repeated use

WARNINGS

Warnings

For external use only

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children. If accidentally

swallowed, get medical help or contact a

Poison Control Center right away.

OTHER SAFETY INFORMATION

Do not get into eye. If contact

occurs, rinse thoroughly with water.

STOP USE

Discontinue use if irritation or redness

develops. If irritation persists for more than

72 hours, consult a doctor.

DOSAGE & ADMINISTRATION

Directions - Apply to hands

until thoroughly wet. Rub

vigorously until dry.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPATHERAPY  
alcohol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53057-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	18 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53057-005-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/15/2014

Labeler - TRIZ LABORATORIES LTD (421290822)

Establishment
Name	Address	ID/FEI	Business Operations
TRIZ LABORATORIES LTD		421290822	manufacture(53057-005)