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

236ml NDC: 43269-983-08

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43269-983
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43269-983-08	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/15/2020	07/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/15/2020	07/15/2022

Labeler - SJ Creations, Inc. (146379495)

Establishment
Name	Address	ID/FEI	Business Operations
McKenna Labs, Inc.		090631412	manufacture(43269-983)

Revised: 9/2021

Document Id: cc1592c4-2589-592f-e053-2995a90a78bb

34390-5

Set id: aa86cdee-13ff-3ceb-e053-2995a90a4f0f

Version: 2

Effective Time: 20210915