Active Ingredient(S)
Ethyl Alcohol 70% v/v. Purpose: Antiseptic, Antimicrobial
Alcohol Based Foaming Hand Sanitizer Approval Label
Alcohol Based Foaming Hand Sanitizer
FDA Label NDC 71023-440
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by National Chemical Laboratories, Inc. for the product Alcohol Based Foaming Hand Sanitizer (NDC 71023-440). 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, 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, Antimicrobial
See Image "Alcohol Based Foaming Hand Sanitizer Approval Label"
Use
• Hand sanitizing to help reduce microorganisms on the skin • Recommended for repeated use
• Use this product when soap and water are not available • Do not use when hands are visibly soiled
See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"
Warnings
For external use only.
FLAMMABLE. Keep away from fire or flame, heat, sparks and sources of static discharge.
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Do Not Use
- Stop use if irritation or redness develops, if condition persist for more than 72 hours consult a physician.
- See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"
Otc - When Using
When using this product avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"
Otc - Stop Use
Stop use if irritation or redness develops, if condition persist for more than 72 hours consult a physician.
See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"
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.
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Directions
- • Apply sufficient product in your palm to cover hands and rub hands together briskly until dry.
• For children under six years of age, hand sanitizer should only be used with adult supervision. See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"
Other Information
- FLAMMABLE. Keep away from fire or flame, heat, sparks and sources of static discharge.
See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"
Inactive Ingredients
Cocamidopropyl PG-Dimonium Chloride Phosphate, Denatonium benzoate, Dimethicone PEG-7 Phosphate, PEG-8 Dimethicone, PEG-10 Dimethicone, tert-Butyl alcohol, Water
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Package Label - Principal Display Panel
1000 ml NDC: 71023-440-57
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