RUE21 STRAWBERRY ANTIBACTERIAL 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.

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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 inhale or 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:

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.

lablabel

RUE21 STRAWBERRY ANTIBACTERIAL HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50563-140
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL63 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER33.79985 mL  in 100 mL
CARBOMER COPOLYMER TYPE A 
TROLAMINE 
EDETATE DISODIUM 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-140-0129 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/09/2013
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Aidi Cosmetics Co., Ltd.530876820manufacture(50563-140)

Revised: 7/2013
Document Id: 2d276c45-839e-440a-ac0f-0e04bfaff19e
Set id: cc58331d-d96c-4c06-97c2-477606ff5d8d
Version: 1
Effective Time: 20130709
 
ENCHANTE ACCESSORIES INC.