Active Ingredient
Alcohol 75% v/v. Purpose: Antiseptic
75% Alcohol Hand Sanitizer
FDA Label NDC 78615-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Narwhal, Inc. for the product 75% Alcohol Hand Sanitizer (NDC 78615-001). 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, directions, warnings, otc - do not use, 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 senitizer
Uses
Hand sanitizer to help decrease bacteria on the skin when water, soap, and towel are not available. Recommended for repeated use.
Directions
Place enough product into your palms and thoroughly spread on both hands.
Rub into skin until dry.
Children under 6 years old must be supervised using this product.
Avoid contact with eyes; in case of contact, flush with water.
Warnings
For external use only.
Flammable. Keep away from fire or flame.
Otc - Do Not Use
Do not apply around eyes. Do not use in ears & mouth.
Otc - Stop Use
Stop use and ask a doctor if redness or irritation develop and persist 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 immediately.
Inactive Ingredients
Carbomer, triethanolamine, glycerin, water
Other Safety Information
Store below 110°F (43°C). May discolor certain fabrics or surfaces.
Package Label - Principal Display Panel
237 mL NDC: 78615-001-01
Pdp (78615 001 01)
500 mL NDC: 78615-001-02
Pdp (78615 001 02)
1000 mL NDC: 78615-001-03
Pdp (78615 001 03)
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