Rue21 Ocean Anti-Bacterial Hand Sanitizer (Alcohol) Liquid [Alily (Zhangzhou) Bath Products Ltd.] -

RUE21 OCEAN ANTI-BACTERIAL HAND SANITIZER (ALCOHOL) LIQUID [ALILY (ZHANGZHOU) BATH PRODUCTS LTD.]
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NDC	49371-043-01
Set ID	5b6d397f-7a6f-4438-a44a-6151eeb62d13
Category	HUMAN OTC DRUG LABEL
Packager	ALILY (ZHANGZHOU) BATH PRODUCTS LTD.
Generic Name
Product Class
Product Number
Application Number	PART333

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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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

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

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

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

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