RUE 21 DREAM DANCE LOVE VANILLA SPICE ANTI BACTERIAL HAND SANITIZER- alcohol liquid

RUE 21 Dream Dance Love Vanilla Spice Anti Bacterial Hand Sanitizer by

Drug Labeling and Warnings

RUE 21 Dream Dance Love Vanilla Spice Anti Bacterial 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 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
  

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

RUE 21 DREAM DANCE LOVE VANILLA SPICE ANTI BACTERIAL HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-170
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: 50563-170-01	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(50563-170)