Active Ingredient
Ethyl Alcohol 70% v/v. Purpose: Antiseptic
Hand Sanitizer Gel
FDA Label NDC 67623-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biocosmetica Excel Argentina for the product Hand Sanitizer (NDC 67623-002). 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, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic, Hand Sanitizer
Uses
Decreases bacteria on skin that pontetially can cause disease
Recommended for repeated use.
Warnings
For external use only.
Flammable. Keep away from heat or flame
When using this product, avoid contact with eyes, ears and mouth. In case of contact with eyes flush thoroughly with water.
Do Not Use
- In children less than 2 months of age.
- On open skin wounds.
Otc - When Using
When using this product, avoid contact with eyes, ears, and mouth. In case of contact with eyes flush thoroughly with water.
Stop use and ask a doctor if redness or irritation develops & persists for more than 72 hours.
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 redness or irritation develops & persits for more than 72 hours.
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
- Wet hands thoroughly with product and allow to dry.
- Children under 6 years of age, use only under adult supervision.
Inactive Ingredients
Water (Aqua), Carbomer, Triethanolamine, Fragrance (Parfum), Phospholipids, Polyquaternium-16, BHT, Panthenol, Niacinamide, Dimethicone, Bisabolol, Phenoxyethanol, Tocopheryl Acetate, CI 16035
Fromsoybean lecithin. FD&C RED 40.
Other Information
Do not store above 105F (43C).
May discolor some fabrics and surfaces.
Package Label.Principal Display Panel
EXEL
ALCOHOL EN GEL ANTIMICROBIANO
con liposomas humectantes y suavizantes
ALCOOL GEL ANTIMICROBIANO
com lipossomas de acao humectante e suavizante
HAND SANITIZER
with moisturizing and softening liposomes
BIOCOSMETICA PROFESIONAL
1.69 fl. Oz/50 ml e
Usa-490-todos-0720 (Usa 490 Todos 0720)
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