Medicinal / Active Ingredient:
Isopropyl alcohol 75% v/v
Maple Cross 75 Isopropyl Antibacterial
FDA Label NDC 77216-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Maple Cross Health Inc. for the product Maple Cross 75 Isopropyl Antibacterial (NDC 77216-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding medicinal / active ingredient:, purpose:, non medicinal / inactive ingredients:, indications:, directions:, warning:, keep out of reach of children., stop use and ask/ consult a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 (Label)
Package Labeling:77216-003-02
Label2 (Label2)
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