Hand Sanitizer by SJ Creations, Inc. / McKenna Labs, Inc. Drug Facts

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by SJ Creations, Inc., McKenna Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- ethyl alcohol gel 
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.

Do not use

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

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 develops.

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

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

Other information

  • Store between 20-25C (68-77F)
  • May discolor some fabrics or surfaces
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

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

Package Label - Principal Display Panel

CM9509-C236ml NDC: 43269-983-08

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43269-983
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)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER 934 (UNII: Z135WT9208)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43269-983-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/15/202007/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/15/202007/15/2022
Labeler - SJ Creations, Inc. (146379495)
Establishment
NameAddressID/FEIBusiness Operations
McKenna Labs, Inc.090631412manufacture(43269-983)

Revised: 9/2021
 

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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