GLITTER RITZ GOLDEN VANILLA EMBERS- alcohol gel 
Landy International

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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Active Ingredient                                     Purpose

Alcohol denat. 63% .................................. Antiseptic

Uses

to decrease bacteria on the skin

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Hand Sanitizer

30 ml 1.0 fl.oz.

Warnings

For external use only.

Flammable.

Keep away from heat and flame.

When using this product

Stop use and ask a doctor if

irritation and redness develop and persist for more than 72 hours.

Directions

Inactive Ingredients

alcohol denat., water, propylene glycol, acrylates/c10-30 alkyl acrylate crosspolymer, aminomethyl propanol, fragrance, lactose, cellulose, hydroxypropyl methylcellulose, jojoba esters, tocopheryl acetate, yellow 5 (CI 19140), red 4 (CI 14700)

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GLITTER RITZ GOLDEN VANILLA EMBERS 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-513
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63   in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
LACTOSE (UNII: J2B2A4N98G)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51706-513-0163 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/15/2015
Labeler - Landy International (545291775)
Establishment
NameAddressID/FEIBusiness Operations
Landy International545291775manufacture(51706-513)

Revised: 4/2015
Document Id: 97fd5a2d-b5b0-44ad-b9db-16f7a46f6a9a
Set id: dd811dbb-9506-4613-99f4-8e1f4cb37764
Version: 3
Effective Time: 20150417
 
Landy International