FDA Label for Alcohol
View Indications, Usage & Precautions
Alcohol Product Label
The following document was submitted to the FDA by the labeler of this product Ignacio Reyes Gonzalez. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
This is a Isorpopyl Alcohol manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The Isopropyl Alcohol is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Isopropyl Alcohol (USP or Food Chemical Codex (FCC) grade) (96%, volume/volume (v/v)) in an liquid solution denatured
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Active Ingredient(S)
Alcohol 96% v/v. Purpose: First aid Antiseptic
Purpose
First Aid Antiseptic
Use
First aid to help prevent the risk of infection in minor cuts, scrapes and burns.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- do not use with electricautery procedures
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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
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
- Clean the affected area, apply small amount of this product 1 to 3 times daily.
- May be covered with a sterile bandaged, let dry first.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredient
Purified Water
Package Label - Principal Display Panel
743 mL NDC: 77196-004-01
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