Active Ingredient
Alcohol 70% v/v.
Alcohol Antiseptic 70% Topical Solution Gel
FDA Label NDC 68400-489
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc for the product Alcohol Antiseptic 70% Topical Solution (NDC 68400-489). 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, otc - purpose, use(s), warnings, do not use, otc - when using, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Antiseptic
Use(S)
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 heat or flame
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
water, glycerin, isopropyl myristate, carbomer, tocopheryl acetate, triethanolamine
Package Label.Principal Display Panel
Keystone_handsanitizer_bulk_container_4911083.jpg (Keystone Handsanitizer Bulk Container 4911083)
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