Your browser does not support JavaScript! RUE 21 APPLE ANTI BACTERIAL HAND SANITIZER (ALCOHOL) LIQUID [ENCHANTE ACCESSORIES INC. ]
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RxNorm Names

RUE 21 APPLE ANTI BACTERIAL HAND SANITIZER (alcohol) liquid
[ENCHANTE ACCESSORIES INC. ]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

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

  • Rub a dime size drop into hands

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 APPLE ANTI BACTERIAL HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50563-168
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:50563-168-0129 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/09/2013
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Aidi Cosmetics Co., Ltd.530876820manufacture(50563-168)

Revised: 11/2013
 
ENCHANTE ACCESSORIES INC.

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