Purpose:
Purpose: Antiseptic
Acqua Aroma Hand Sanitizer Gel
FDA Label NDC 70848-410
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Smell It Industria E Comercio Ltda for the product Acqua Aroma Hand Sanitizer Gel (NDC 70848-410). 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 purpose:, use, warnings, (for 1.0 fl oz) warnings:, (for 12.9 fl oz) warnings:, (for 1.0 fl oz) warnings, other information:, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
Decreases
Use (Drugfacts 1 Floz)
Warnings
Flammable. Keep away from flame or high heat.
For external use only.
Stop use and ask a doctor if irritation and redness develop or increase.
(For 1.0 Fl Oz) Warnings:
When using this product avoid contact with eyes.
(For 12.9 Fl Oz) Warnings:
When using this product avoid contact with eyes. If contact occurs, rinse with water.
Keep out reach of Children. Children under 6 year old should be supervised when using it. If swallowed, get medical help or contact a Poison Control Center right away.
(For 1.0 Fl Oz) Warnings
Keep out reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.
Other Information:
Store below 104°F (40°C). May discolor certain fabrics or surfaces.
Directions
Rub into hands until dry.
(For 1.0 Fl Oz) Inactive Ingredients:
Inactive ingredients: Water (Aqua), Methyl Gluceth-20, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Fragrance (Parfum), Aminomethyl Propanol, Mannitol, Cellulose, Citronellol, Linalool, Alpha-isomethyl Ionone, Coumarin, CI 77492, D-limonene, Geraniol, Tocopheryl Acetate, Hydroxypropyl Methylcellulose.
(For 12.9 Fl Oz) Inactive Ingredients:
Inactive Ingredients: Water (Aqua), Acrylates C10-30 Alkyl Acrylate Crosspolymer, Methyl Gluceth-20, Fragrance (Parfum), Aminomethyl Propanol, Mannitol, Cellulose, Citronellol, Linalool, Alpha-isomethyl Ionone, Acrylates Copolymer, Coumarin, CI 77492, Hydroxypropylcellulose, Mica, CI 77891, D-limonene, Geraniol, Hydroxypropyl Methylcellulose, Triethyl Citrate, Acrylate Ammonium Methacrylate Copolymer, CI 77491, Caprylyl Capryl Glucoside, Caprylic Capric Triglyceride, Lauryl Glucoside, Talc, Tocopheryl Acetate.
(For 1.0 Oz) Primary Panel
Acqua Aroma (Primarypanel 1 Floz)
(For 12.9 Oz) Primary Panel
Acqua Aroma The Scent of Your Home NDC Number With Vitamin E microspheres Hand Sanitizer Gel 12.9 FL OZ (380ML) Kills 99.9% of common bacteria
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