Summit Hand Sanitizer
FDA Label NDC 79190-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Imo Source (pty) Ltd for the product Summit Hand Sanitizer (NDC 79190-000). 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 drug facts, active ingredient(s), purpose, use[s], warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient(S)
Ethyl Alcohol 70% (V/V%)
Purpose
Antiseptic
Use[S]
- To help minimize bacteria on the skin that could cause disease
- Recommended for repeated use
Warnings
For external use only
• Flammable
• Keep away from fire or flame
Do Not Use
- On children less than 2 months of age
- On open skin wounds
When Using This Product
- Keep out of eyes. In case of contact with eyes, flush thoroughly with water
- Avoid contact with broken skin
- Do not inhale or ingest
Stop Use And Ask A Doctor If
irritation, rash or redness develops and persists
Keep Out Of Reach Of Children
- If swallowed, seek medical help or contact a Poison Control Center immediately
Directions
- Apply enough product to cover all areas of hands
- Rub hands together briskly until dry
- Children under 6 years of age require supervision when using this product
Other Information
- Do not store above 105°F
- May cause fabric discoloration
- May harm plastics and wood finishes
Inactive Ingredients
Purified water USP, Glycerol, Hydroxyethylcellulose , Tocopheryl Acetate (Vitamin E), Benzalkonium Chloride, Tetrasodium EDTA, Citric Acid.
Package Labeling
Bottle (Bottle)
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