HAND SANITIZER- alcohol gel 
BLAKEMORE SALES CORPORATION

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.

----------

Hand Sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

Warnings

For external use only.

Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age or on open skin wounds

When using this product

  • Keep out of eyes and mouth.

     In case of contact with eyes, rinse eyes thoroughly with water

Stop use and ask a doctor

if irritation or redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Water, Glycerin, Aloe Barbadensis Extract, Aminomethyl Propanol, Porpylene Glycol, Carbomer, Fragrance, Toopherol.

Package Labeling: 500ml

Label

Package Labeling: 1000ml

Label2

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78304-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78304-004-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/21/2020
2NDC:78304-004-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/21/2020
Labeler - BLAKEMORE SALES CORPORATION (164380578)
Establishment
NameAddressID/FEIBusiness Operations
Yuyao Huanyan Daily Chemical Products Co., Ltd554527491manufacture(78304-004)

Revised: 6/2020
Document Id: a703510a-e356-5df6-e053-2995a90a6526
Set id: 984bae9e-79ba-4fb0-be45-efececa1900d
Version: 1
Effective Time: 20200601
 
BLAKEMORE SALES CORPORATION