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 spray 
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 74% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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.

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Glycerin,Citrus Paradisi (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Aloe Barbadensis Leaf Extract, Althaea Officinalis Root Extract, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Limon (Lemon) Peel Extract, Cymbopogon Schoenanthus Leaf/Stem Extract, Equisetum Arvense Extract, Humulus Lupulus (Hops) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Sclarea (Clary) Extract, Vaccinium Myrtillus Fruit/Leaf Extract, Yucca Schidigera Leaf/Root/Stem Extract.

Package Label - Principal Display Panel

251ml NDC: 43269-975-08

HAND SANITIZER 
ethyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43269-975
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	74 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LEMON OIL (UNII: I9GRO824LL)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
CHAMOMILE (UNII: FGL3685T2X)
ORANGE PEEL (UNII: TI9T76XD44)
LEMON PEEL (UNII: 72O054U628)
HUMULUS LUPULUS WHOLE (UNII: 912A6Q1N4A)
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)
VACCINIUM MYRTILLUS WHOLE (UNII: EE76EZ4QNZ)
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)
CYMBOPOGON SCHOENANTHUS WHOLE (UNII: RJJ0F54DE8)
EQUISETUM ARVENSE WHOLE (UNII: 73DM367W4P)
SALVIA SCLAREA WHOLE (UNII: I0440F92M2)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43269-975-08	251 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/10/2020	01/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/10/2020	01/19/2023

Labeler - SJ Creations, Inc. (146379495)

Establishment
Name	Address	ID/FEI	Business Operations
McKenna Labs, Inc.		090631412	manufacture(43269-975)

Revised: 1/2023

Document Id: f2aa153c-f490-f6bd-e053-2a95a90a1c85

34390-5

Set id: aa18f1f8-8e61-3acb-e053-2a95a90ab5fe

Version: 2

Effective Time: 20230119