RUE21 RUNWAY 21 ANTIBACTERIAL HAND SANITIZER- alcohol liquid

RUE21 Runway 21 Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

RUE21 Runway 21 Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by ENCHANTE ACCESSORIES INC. , Zhejiang Aidi Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol 63%

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

To decrease bacteria on the skin

WARNINGS

For external use only

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

 

ASK DOCTOR

Stop use and ask a doctor if skin irritation develops

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical assistance.

DOSAGE & ADMINISTRATION

Directions

• Rub a dime size drop into hands
  

STORAGE AND HANDLING

Other Information:

• Do not store above 105F
• May discolor some fabrics

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

lab

INGREDIENTS AND APPEARANCE

RUE21 RUNWAY 21 ANTIBACTERIAL HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-143
Route of Administration	TOPICAL

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: 50563-143-01	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	07/09/2013

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(50563-143)