SPATHERAPY GRAPEFRUIT NECTAR - alcohol lotion 
TRIZ LABORATORIES LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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,

FD and C Red 4 CI 14700, FD and C Yellow 5 CI 42090

Active Ingredient

Alcohol Denat 60 % w/w

Purpose Antibacterial

Use - To decrease bacteria

on the skin and clean hands - Recommended

for repeated use

Warnings

For external use only.

Flammable, keep away from fire or flame

Keep Out of Reach of Children. If accidentally

swallowed, get medical help or contact a

Poison Control Center right away.

Do not get into eye. If contact

occurs, rinse thoroughly with water.

Discontinue use if irritation or redness

develops. If irritation persists for more than

72 hours, consult a doctor.

Directions - Apply to hands

until thoroughly wet. Rub

vigorously until dry.

copy of label

SPATHERAPY GRAPEFRUIT NECTAR 
alcohol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53057-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL18 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 RED NO. 4 (UNII: X3W0AM1JLX)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53057-019-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/18/2015
Labeler - TRIZ LABORATORIES LTD (421290822)
Establishment
NameAddressID/FEIBusiness Operations
TRIZ LABORATORIES LTD421290822manufacture(53057-019)

Revised: 2/2015
Document Id: 2ee33f12-9597-4372-97c6-b2f1c1e38783
Set id: e046ab64-4f75-43f8-8652-64149731c650
Version: 1
Effective Time: 20150218
 
TRIZ LABORATORIES LTD