Hand Sanitizer by SJ Creations, Inc. / Tonic Bath & Body Products Shenzhen Ltd Drug Facts

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by SJ Creations, Inc., Tonic Bath & Body Products Shenzhen Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- ethyl alcohol 
SJ Creations, Inc.

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 Facts

Active Ingredient(s)

Ethyl Alcohol 65% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.

Flammable. Keep away from fire and flame.

When using this product avoid contact with eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Put enough on your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product

Other information

  • Store at 20-25C (68-77F)
  • May discolor some fabrics or surfaces

Inactive ingredients

Water, Glycerin, Propylene Glycol, Carbomer, Fragrance, Tocopheryl Acetate, Isopropyl Alcohol, Aminomethyl Propanol, Isopropyl Palmitate.

Package Label - Principal Display Panel

2 x 59 ml Bottles in Blister Pack NDC: 43269-128-04

201334

HAND SANITIZER 
ethyl alcohol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43269-128
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43269-128-041 in 1 BLISTER PACK; Type 0: Not a Combination Product10/07/202010/07/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, DISPENSING 65 mL  in 100 
Part 21 BOTTLE, DISPENSING 65 mL  in 100 
Part 1 of 2
ETHYL ALCOHOL 
hand sanitizer gel
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
159 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/07/2020
Part 2 of 2
ETHYL ALCOHOL 
hand sanitizer gel
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
159 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/07/202010/07/2022
Labeler - SJ Creations, Inc. (146379495)
Establishment
NameAddressID/FEIBusiness Operations
Tonic Bath & Body Products Shenzhen Ltd528197042manufacture(43269-128)

Revised: 9/2021
Document Id: cbe6da96-8a6b-d8af-e053-2a95a90aaab3
Set id: b1229495-deb9-d784-e053-2a95a90a289e
Version: 2
Effective Time: 20210913
 

Trademark Results [Hand Sanitizer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HAND SANITIZER
HAND SANITIZER
88958909 not registered Live/Pending
MAISON BLANCHE, LLC
2020-06-10
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