MAPLE CROSS 80 ETHANOL HAND SANITIZER- alcohol liquid 
Maple Cross Health 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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Maple Cross 80% Ethanol Hand Sanitizer

Drug Facts:

Medicinal / Active ingredient:

Ethyl alcohol 80% v/v

Purpose:

Antiseptic

Non medicinal / Inactive ingredients:

Water (Aqua), Glycerin, Hydrogen peroxide, Denatonium benzoate. This product does not contain mercury.

Indications:

For personal hand hygiene to help prevent the spread of bacteria.

Directions:

Rub thoroughly into hands for at least 30 seconds. Allow to dry. For occasional and personal domestic use. Supervise children when they use this product.

Warning:

Flammability warning. Keep away from open flame and sources of heat. For external use only.

Keep out of reach of children.

If swallowed, call a poison control centre or get medical help right away.

Stop use and ask/ consult a doctor/physician/

health care practitioner/ health care provider/ health care professional if irritation develops.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Contraindications:

Do not use on children/infants less than 2 years of age (unless directed by a doctor/ physician/ health care practitioner/ health care provider/ health care professional).

Other information:

Store below 110°F (43°C). May discolour certain fabrics or surfaces.

Package Labeling: 300ml

Label

Package Labeling: 500ml

Label2

Package Labeling: 1000ml

Label3

MAPLE CROSS 80 ETHANOL HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77216-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77216-000-00300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
2NDC:77216-000-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
3NDC:77216-000-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2020
Labeler - Maple Cross Health Inc. (204125678)

Revised: 5/2020
Document Id: a564e57e-c6ed-9046-e053-2995a90a3425
Set id: d95f56ac-887d-4fd9-b8f4-8ffc66ea2f79
Version: 1
Effective Time: 20200511
 
Maple Cross Health Inc.