SPATHERAPHY- alcohol lotion

Spatheraphy by

Drug Labeling and Warnings

Spatheraphy 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, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,

Triethonalamine, Fragrance, PEG-40 Hydrogenated

Castor Oil, May contain:

D C Red 33, FD C Red 4, FD C Yellow 5, FD C Blue 1

ACTIVE INGREDIENT

Active Ingredient

Alcohol Denat 62 % 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.

STOP USE

Discontinue use if irritation or redness develop. If irritation persists

for more than 72 hours, consult a doctor.

Do not get into eye. If contact occurs, rinse thoroughly with water.

DOSAGE & ADMINISTRATION

Directions - Apply to hands until thoroughly wet - Rub

vigorously until dry.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPATHERAPHY  
alcohol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56136-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	18.6 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)
CASTOR OIL (UNII: D5340Y2I9G)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
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: 56136-002-01	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	10/01/2013

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(56136-002)