MAPLE CROSS 75 ISOPROPYL ANTIBACTERIAL- isopropyl alcohol cloth 
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 75% Isopropyl Antibacterial

Drug Facts:

Medicinal / Active ingredient:

Isopropyl alcohol 75% v/v

Purpose:

Antiseptic

Non medicinal / Inactive ingredients:

Water (Aqua). This product does not contain mercury.

Indications:

Medicated (skin) cleanser. Effective in destroying (harmful) bacteria to provide  antiseptic cleansing.

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:77216-003-01

Label

Package Labeling:77216-003-02

Label2

MAPLE CROSS 75 ISOPROPYL ANTIBACTERIAL 
isopropyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77216-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77216-003-0150 in 1 CANISTER07/15/2020
13 mL in 1 PATCH; Type 0: Not a Combination Product
2NDC:77216-003-02100 in 1 CANISTER07/15/2020
23 mL in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/15/2020
Labeler - Maple Cross Health Inc. (204125678)

Revised: 7/2020
Document Id: a9dff7df-15c6-c86a-e053-2a95a90a2c9c
Set id: a9dff31d-7677-44dc-e053-2995a90a912e
Version: 1
Effective Time: 20200707
 
Maple Cross Health Inc.