ICEE WHITE CHERRY SCENTED HAND SANITIZER - alcohol liquid 
Zhejiang Blue Dream Cosmetics Co., Ltd.

Disclaimer: 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.

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DRUG FACT

Active Ingredient      Ethyl Alcohol     62%



Purpose                      Antiseptic



Uses:

To decrease bacteria on skin that could cause disease

Recommended for repeated use


Warnings:

For external use only

Flammable. Keep away from heat and flame.

When using this product

    * 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.



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



Other Information

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

Water, Sodium Lauryl Sulfate, Carbomer, Glycerin, Triethanolamine, Fragrance, PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin, Hydrogenated Jojoba Oil, Aloe and Vitamin E Microbeads. May Contain: FD and C Blue No. 1, FD and C Red No. 40, FD and C Yellow No. 5

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ICEE WHITE CHERRY SCENTED HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34460-6009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 35.16 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 0.2 g  in 100 g
TROLAMINE (UNII: 9O3K93S3TK) 0.2 g  in 100 g
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC) 0.2 g  in 100 g
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.1 g  in 100 g
DMDM HYDANTOIN (UNII: BYR0546TOW) 0.02 g  in 100 g
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.002 g  in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.003 g  in 100 g
FD&C RED NO. 40 (UNII: WZB9127XOA) 0.005 g  in 100 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 2 g  in 100 g
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.01 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34460-6009-145 g in 1 BOTTLE
2NDC:34460-6009-290 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/07/2010
Labeler - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234)
Registrant - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Blue Dream Cosmetics Co., Ltd.529047234manufacture

Revised: 10/2010
Document Id: 8dfdad81-4f0d-4187-af6e-0c48d2d76403
Set id: ce94e174-0905-4345-b824-4ef4a2e0bb28
Version: 1
Effective Time: 20101007
 
Zhejiang Blue Dream Cosmetics Co., Ltd.