Otc - Active Ingredient
Active Ingredients ......... Purpose
70% Ethyl Alcohol (v/v)........ Antiseptic
Amass Basilisk Breath Hand Sanitizer Serum
FDA Label NDC 77419-2003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amass Brands, Inc for the product Amass Basilisk Breath Hand Sanitizer Serum (NDC 77419-2003). 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 otc - active ingredient, use, otc - keep out of reach of children, otc - purpose, otc - stop use, otc - when using, other safety information, warnings and precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
Do not use in or near the eyes. In case of contact, rinse thoroughly with water.
Do Not (Warnings)
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical attention or contact a poison center immediately.
Do Not (Warnings)
Otc - Purpose
USE
Hand sanitizer to help reduce disease-causing bacteria
Purpose (Use)
Otc - Stop Use
Stop use and ask a doctor if irriation or rash occurs.
Do Not (Warnings)
Otc - When Using
Directions
Apply liberally to dry hands, rub briskly until evaporated
Children should be supervised when using this product
When Using (Directions)
Other Safety Information
OTHER INFORMATION
Avoid freezing and excessive heat above 104F (40C)
Warnings And Precautions
WARNINGS
Flammable. Keep away from heat or flame.
For external use only.
Do not use in or near the eyes. In case of contact, rinse thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs.
Keep out of reach of children. IF swallowed, get medical attention or contact a poison center immediately.
Do Not (Warnings)
Instructions For Use
DIRECTIONS
Apply liberally to dry hands, rub briskly until evaporated.
Children should be supervised when using this product
When Using (Directions)
Inactive Ingredient
INACTIVE INGREDIENTS
Aqua, Glycerin, Ocimum Basilicum (Sweet Basil) Oil, Mentha Piperita (Peppermint) Oil, Salvia Rosmarinus (Rosemary) Oil, Salvia Officinalis (Sage) Oil, Thymus Vulgaris (Thyme) Oil, Linalool, Eugenol, Hydroxypropyl Cellulose, Lauryl Lactate, Myristyl Lactate, Cetyle Lactate
Inactive (Ingredients)
Dosage & Administration
DIRECTIONS
Apply liberally to dry hands, rub briskly until evaporated.
Children should be supervised when using this product
When Using (Directions)
Warnings
WARNINGS
Flammable. Keep away from heat or flame.
For external use only.
Do not use in or near the eyes. In case of contact, rinse thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs.
Keep out of reach of children. IF swallowed, get medical attention or contact a poison center immediately.
Do Not (Warnings)
Indications & Usage
USE
Hand sanitizer to help reduce disease-causing bacteria.
Purpose (Use)
Package Label.Principal Display Panel
B+N
AMASS
BASILISK BREATH
BASIL
PEPPERMINT
ROSEMARY
SAGE
THYME
70% Alcohol-based hand sanitizer for when water is not available. Manufactured in Los Angeles, California.
1 gal 3.785L
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