Active Ingredient
Ethyl Alcohol 75%
Aloha Gel Hand Sanitizer Pure Peppermint
FDA Label NDC 74657-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Double Body Biotech Limited for the product Aloha Gel Hand Sanitizer Pure Peppermint (NDC 74657-014). 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 active ingredient, purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, otc - do not use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
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 fire and flame.
Otc - Stop Use
Stop use and consult a doctor if irritation or rash appears.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Do Not Use
If swallowed, seek medical attention immediately.
Directions
Wet hands thoroughly with gel, rub vigorously and allow to dry without wiping.
Other Information
Store below 105°F
may discolor certain fabrics
Inactive Ingredient:
(only for Package NDC: 74657-010-01; 74657-010-05; 74657-010-10)*
Water, Glycerin, Carbomer, Propylene Glycol, Aloe Barbadensis Leaf Extract.
(only for Package NDC: 74657-011-01)*
Water, Glycerin, Carbomer, Propylene Glycol, Aloe Vera Leaf, Frangrance, FD&C Red No. 40, FD&C Yellow No. 5.
(only for Package NDC: 74657-012-01)*
Water, Glycerin, Carbomer, Propylene Glycol, Aloe Vera Leaf, Frangrance, FD&C Red No. 33.
(only for Package NDC: 74657-013-01)*
Water, Glycerin, Carbomer, Propylene Glycol, Aloe Vera Leaf, Frangrance, FD&C Red 40, FD&C Yellow No. 5.
(only for Package NDC: 74657-014-01)*
Water, Glycerin, Carbomer, Propylene Glycol, Aloe Vera Leaf, Frangrance, FD&C Blue No. 1, FD&C Yellow No. 5.
(only for Package NDC: 74657-015-01)*
Water, Glycerin, Carbomer, Propylene Glycol, Aloe Vera Leaf, Frangrance
*Remark: , All words in the brackets are not shown on the labels.
Package Label.Principal Display Panel
1000ml, Package NDC: 74657-010-10; 500ml, Package NDC: 74657-010-05; 100ml, Package NDC: 74657-010-01; 60ml, Product NDC: 74657-011-01; 60ml, Product NDC: 74657-012-01; 60ml, Product NDC: 74657-013-01; 60ml, Product NDC: 74657-013-01; 60ml, Product NDC: 74657-014-01; 60ml, Product NDC: 74657-015-01
74657-010-01; 74657-010-05; 74657-010-10 (74657 010)
74657-011-01 (74657 011)
74657-012-01 (74657 012)
74657-013-01 (74657 013)
74657-014-01 (74657 014)
74657-015-01 (74657 015)
* Please review the disclaimer below.
