Otc - Active Ingredient
Active ingredient:
Ethyl alcohol 62%
Hand Sanitizer Gel
FDA Label NDC 71927-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Orazen Inc for the product Hand Sanitizer (NDC 71927-005). 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 otc - active ingredient, otc - purpose, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiseptic
Warnings
Warnings
For external use only: hands
Flammable. Keep away from heat and flame.
Otc - Stop Use
Stop use and ask a doctor if
- irritation or redness develops
- condition persists for more that 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(1-800-222-1222) right away.
Dosage & Administration
Directions
- wet hands thoroughly with product and allow to dry without wiping
- for children under 6, ues only under adult supervision
- not recommended for infants
Inactive Ingredient
Inactive ingredients
acrylates/C10-C30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, glycerin, maltodextrin, propylene glycol, triethanolamine, water
Other Safety Information
Other Information
- do not store above 105F
- may discolor some fabrics
- harmful to wood finishes and plastics
Indications & Usage
Uses to decrease bacteria on the skin that could cause disease. recommended for repeated use
Otc - When Using
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
Package Label.Principal Display Panel
Image Of Bottle Label (005)
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