INSTANT HAND SANITIZER FRESH LEMON SCENTED - alcohol liquid 
Ningbo Heyi Daily Chemical Products 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:

    * Hand Sanitizer to help decrease bacteria on the skin.
  
    * Recommended for repeated use.


Warnings:

For external use only

Flammable

Keep away from fire or flame

Keep out of eyes


Keep out of Reach of Children
Children must be supervised in use of this product



Stop use and seek a doctor if redness or irritation develop and persist for more than 72 hours.


Directions:

Apply to hands freely without water. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.


Other Information

Store at 20C (68-77F)

Do not store above 40C (105F)

May discolor fabrics


Inactive Ingredients:

Water, Triethanolamine, Carbomer, Aloe Barbadensis Gel, Glycerin, Propylene Glycol, Tocopherol, FD and C Blue No. 1, FD and C Yellow No. 5

labellabel

INSTANT HAND SANITIZER FRESH LEMON SCENTED 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51335-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 34.289 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51335-005-0160 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/03/2012
Labeler - Ningbo Heyi Daily Chemical Products Co., Ltd. (421258415)
Registrant - Ningbo Heyi Daily Chemical Products Co., Ltd. (421258415)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Heyi Daily Chemical Products Co., Ltd.421258415manufacture(51335-005)

Revised: 8/2012
Document Id: 13b816bb-7336-44af-973e-be95d37d6238
Set id: 4a9b909f-3815-4780-9b3d-4c8e9508b836
Version: 1
Effective Time: 20120803
 
Ningbo Heyi Daily Chemical Products Co., Ltd.