RUE21 OCEAN ANTI-BACTERIAL HAND SANITIZER- alcohol liquid

Rue21 Ocean Anti-Bacterial Hand Sanitizer by

Drug Labeling and Warnings

Rue21 Ocean Anti-Bacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by ALILY (ZHANGZHOU) BATH PRODUCTS LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                        Purpose

Ethyl Alcohol 62%                      Antiseptic

INDICATIONS & USAGE

            Uses:

• To decrease bacteria on the skin that could cause diseases

• Recommended for repeated use.

WARNINGS

Warnings:

For external use only-hands.

Flammable-keep away from heat and flame

When using this products

• keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• Avoid contact with broken skin.
• Do not inhale or ingest.

Stop use and ask a doctor if skin irritation develops.

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION

Directions

• Wet hands thoroughly with product and allow to dry without wiping
• For children under 6, use only under adult supervision
• Not recommended for infants

STORAGE AND HANDLING

    Other Information

• Do not store above 105 F
• May discolor some fabrics
• Harmful to wood finishes and plastics

INACTIVE INGREDIENT

Inactive Ingredients

Water (aqua), Glycerin, Triethanolamine, Fragrance (Parfume), PEG-40 Hydrogenated Castor Oil, Carbomer, DMDM Hydantoin, Hydrogenated Jojoba Oil, FD and C Yellow No. 5, FD and C Blue No. 1

PRINCIPAL DISPLAY PANEL

pict

INGREDIENTS AND APPEARANCE

RUE21 OCEAN ANTI-BACTERIAL HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49371-043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	33.9484 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	2 g  in 100 g
TROLAMINE (UNII: 9O3K93S3TK)	0.3 g  in 100 g
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)	0.3 g  in 100 g
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)	0.8 g  in 100 g
DMDM HYDANTOIN (UNII: BYR0546TOW)	0.2 g  in 100 g
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.0016 g  in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.005 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49371-043-01	45 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	05/20/2010

Labeler - ALILY (ZHANGZHOU) BATH PRODUCTS LTD. (531064269)

Registrant - ALILY (ZHANGZHOU) BATH PRODUCTS LTD. (531064269)

Establishment
Name	Address	ID/FEI	Business Operations
ALILY (ZHANGZHOU) BATH PRODUCTS LTD.		531064269	manufacture