Active Ingredient(S)
Ethyl alcohol (Ethanol)-70 % V/V / Alcool Ethylique 70% V/V
Deljine Hand Sanitizer Gel
FDA Label NDC 78064-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Deljine Cosmetics Corporation for the product Deljine Hand Sanitizer Gel (NDC 78064-001). 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(s), purpose, use, recent major changes, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antibacterial (skin) cleanser. Antiseptic (skin) cleanser. Effective in destroying (harmful) bacteria to provide antiseptic cleansing.
Use
For personal hand hygiene to help prevent the spread of bacteria. Kills harmful bacteria/germs. Medicated (skin) cleanser. For use when soap and water are not available.
Recent Major Changes
For personal hand hygiene to help prevent the spread of bacteria. Kills harmful bacteria/germs. Medicated (skin) cleanser. For use when soap and water are not available.
Warnings
Flammability warning. Keep away from open flame and sources of heat. For external use only.
Do Not Use
- 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). Do not use on open skin wounds
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation or rash develops.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.
Directions
- Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children when they use this product. For occasional and personal domestic use.
Other Information
- Store between 15-30C (59-86F), Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Water/ Aqua/Eau , Ammonium Acryloyldimethyltaurate, Glycerin, Aloe Barbadensis Leaf Juice, d-alpha-tochopheryl Acetate, fragrance (green tea coriander and mandarin)/ parfum (thé vert coriandre et mandarine).
Package Label - Principal Display Panel
Hand sanitizer gel 1000 ml, NDC: 78064-001-10
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