RUE 21 FALLEN VIXEN ANTI BACTERIAL HAND SANITIZER- alcohol liquid 
ENCHANTE ACCESSORIES INC.

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.

----------

Drug Fact

Active Ingredient

Ethyl Alcohol 63%

Purpose

Antiseptic

Uses

To decrease bacteria on the skin

For external use only.

When using this product: Keep out of eyes. Do not ingest.

 

Stop use and ask a doctor if skin irritation develops

Keep out of reach of children.

If swallowed, get medical assistance.

Directions

Other Information

Do not store above 105F

May discolor some fabrics

Inactive Ingredient:

Aqua, Carbomer, Triethanolamine, Parfum, Disodium EDTA, may contain D and C Red No. 33, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

label

RUE 21 FALLEN VIXEN ANTI BACTERIAL HAND SANITIZER 
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-162
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 63 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R) 33.79985 mL  in 100 mL
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50563-162-01 29 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 11/09/2013
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)
Establishment
Name Address ID/FEI Business Operations
Zhejiang Aidi Cosmetics Co., Ltd. 530876820 manufacture(50563-162)

Revised: 11/2013
Document Id: 848a678c-ab24-48ee-b54e-a86468269025
Set id: 52c986d5-107a-4353-8209-2a2e57eae47b
Version: 1
Effective Time: 20131106
 
ENCHANTE ACCESSORIES INC.